Download April through June 2014

April through June 2014
Updated Warnings—Current Drugs
Public Notification Regarding Male Sexual Enhancement Products: The FDA is advising consumers
not to purchase or use GoldReallas, Full Throttle On Demand, 3 Hard Knights, Dick’s Hard Up, Eyeful, Liu Bian Li,
products promoted and sold for sexual enhancement on
various websites and in some retail stores. FDA laboratory
analysis confirmed that these products contained the following undeclared drug ingredients:
• GoldReallas: sildenafil and thiosildenafil
• Full Throttle On Demand: propoxyphenyl sildenafil
• 3 Hard Knights: sildenafil and thiosildenafil
• Dick’s Hard Up: tadalafil
• Eyeful: hydroxythiohomosildenafil
• Liu Bian Li: sildenafil
These undeclared ingredients may interact with nitrates
found in some prescription drugs such as nitroglycerin and
may lower blood pressure to dangerous levels.
Sildenafil is the active ingredient in the FDA approved prescription drug Viagra, used to treat erectile dysfunction
(ED). The other undeclared ingredients are structurally
similar to sildenafil.
Consumers should stop using these products immediately
and throw them away. Consumers who have experienced
any negative side effects should consult a health care professional as soon as possible. (6/3/14)
Asset Bold: Undeclared Drug Ingredient: The FDA
is advising consumers not to purchase or use Asset Bold, a
product promoted and sold for weight loss. FDA laboratory
analysis confirmed that Asset Bold contains sibutramine.
Sibutramine is a controlled substance that was removed
from the market in October 2010 for safety reasons. The
product poses a threat to consumers because sibutramine
is known to substantially increase blood pressure and/or
pulse rate in some patients and may present a significant
risk for patients with a history of coronary artery disease,
congestive heart failure, arrhythmias, or stroke. These
products may also interact, in life-threatening ways, with
other medications a consumer may be taking.
Asset Bold is a product promoted and sold for weight loss
on various websites and in some retail stores.
The FDA is recommending that consumers do not purchase
or use Asset Bold. (5/16/14)
Undeclared Drug Ingredient Found in MV5 Days:
The FDA is advising consumers not to purchase or use
MV5 Days, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that MV5
Days contains sildenafil, the active ingredient in the FDA
approved prescription drug Viagra, used to treat ED. This
undeclared ingredient may interact with nitrates found in
some prescription drugs such as nitroglycerin and may
lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease
often take nitrates.
MV5 Days is a product promoted and sold for sexual enhancement on various websites and in some retail stores.
FDA is recommending that consumers do not purchase or
use MV5 Days. (5/16/14)
Lunesta—Next Day Impairments: The FDA has notified health professionals and their medical care organizations of a new warning that the insomnia drug Lunesta
(eszopiclone) can cause next-day impairment of driving
and other activities that require alertness. FDA recommends a decreased starting dose of Lunesta to 1 mg at bedtime. Women and men are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1
mg is the same for both. FDA approved changes to the
Lunesta prescribing information and the patient Medication Guide to include these new recommendations. The
drug labels for generic eszopiclone products will also be
updated to include these changes.
A study of Lunesta found that the previously recommended
dose of 3 mg can cause impairment to driving skills,
memory, and coordination that can last more than 11 hours
after receiving an evening dose. Despite these driving and
other problems, patients were often unaware they were
impaired. The new lower recommended starting dose of 1
mg at bedtime will result in less drug in the blood the next
day.
Health care professionals should follow the new dosing
recommendations when starting patients on Lunesta. Patients should continue taking their prescribed dose of
Lunesta and contact their health care professionals to ask
about the most appropriate dose for them. FDA is continuing to evaluate the risk of impaired mental alertness with
the entire class of sleep aid drugs, including over-thecounter drugs available without a prescription, and will
update the public as new information becomes available.
(5/15/14)
www.AmericanHealthCare.com
For informational purposes only, consult a physician for any drug changes.
“FDA” stands for the United States Food and Drug Administration.
Even with FDA approval, drug availability depends on each manufacturer.
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Pradaxa Study by FDA: Increased Risk of GI Bleeding: The FDA recently completed a new study in Medicare
patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and
death. The new study found that among new users of
blood-thinning drugs, Pradaxa was associated with a lower
risk of clot-related strokes, bleeding in the brain, and
death, than warfarin. The study also found an increased
risk of major gastrointestinal bleeding with use of Pradaxa
as compared to warfarin. The MI risk was similar for the
two drugs.
Importantly, the new study is based on a much larger and
older patient population than those used in FDA’s earlier
review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events
of concern. As a result of these latest findings, the FDA still
considers Pradaxa to have a favorable benefit to risk profile
and have made no changes to the current label or recommendations for use.
Pradaxa and warfarin are used to reduce the risk of stroke
and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation
(AF).
Patients should not stop taking Pradaxa (or warfarin) without first talking with their health care professionals. Stopping the use of blood-thinning medications such as
Pradaxa and warfarin can increase the risk of stroke and
lead to permanent disability and death. Health care professionals who prescribe Pradaxa should continue to follow
the dosing recommendations in the drug label. (5/13/14)
Asset Bee Pollen—Undeclared Drug Ingredient:
The FDA is advising consumers not to purchase or use Asset Bee Pollen, a product promoted and sold for weight
loss. FDA laboratory analysis confirmed that Asset Bee Pollen contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010
for safety reasons. The product poses a threat to consumers
because sibutramine is known to substantially increase
blood pressure and/or pulse rate in some patients and may
present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias,
or stroke. These products may also interact, in lifethreatening ways, with other medications a consumer may
be taking.
Asset Bee Pollen is a product promoted and sold for weight
loss on various websites.
The FDA is recommending patients not purchase or use
Asset Bee Pollen. (5/12/14)
Natural Body Solution—Undeclared Drug Ingredient: The FDA laboratory analysis confirmed that Natural
Body Solution contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to
consumers because sibutramine is known to substantially
increase blood pressure and/or pulse rate in some patients
and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. These products may also interact, in
life-threatening ways, with other medications a consumer
may be taking.
Natural Body Solution is promoted and sold for weight loss
and sold on various websites and in some retail stores.
FDA is advising consumers not to purchase or use Natural
Body Solution. (5/6/14)
Slim Trim U: Undeclared Drug Ingredient Found:
The FDA laboratory analysis confirmed that Slim Trim U
contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010
for safety reasons. The product poses a threat to consumers
because sibutramine is known to substantially increase
blood pressure and/or pulse rate in some patients and may
present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias,
or stroke. These products may also interact, in lifethreatening ways, with other medications a consumer may
be taking.
Slim Trim U is promoted and sold for weight loss and sold
on various websites and in some retail stores.
FDA is advising consumers not to purchase or use Slim
Trim U. (5/6/14)
GenStrip Blood Glucose Test Strip—Safety Risk:
The FDA is advising people with diabetes and health care
professionals to stop using GenStrip Blood Glucose Test
Strips because the strips may report incorrect blood glucose levels.
During a recent inspection of Shasta Technologies LLC, the
FDA found extensive violations of federal regulations intended to assure the quality of products in the manufacturing of GenStrip Test Strips. FDA found that Shasta Technologies did not have in place many of the requirements of
a quality system. Without assurance of an adequate quality
system, the FDA believes that the strips could report incorrect blood glucose levels.
GenStrip Blood Glucose Test Strips, sold by Shasta Technologies LLC, are "third-party" blood glucose monitoring
test strips. Shasta’s GenStrips are advertised for use with
the LifeScan OneTouch family of glucose meters (e.g. Ultra,
Ultra 2 and Ultra Mini).
Discontinue use of GenStrip Blood Glucose Test Strips.
FDA recommends the use of alternative glucose test strips
that are designed for use with the LifeScan OneTouch family of glucose meters. (4/29/14)
FDA Finds Undeclared Drug Ingredients in
S.W.A.G: The FDA is advising consumers not to purchase
or use S.W.A.G, a product promoted and sold for sexual
enhancement. FDA laboratory analysis confirmed that
S.W.A.G contains sildenafil, the active ingredient in the
FDA approved prescription drug Viagra, used to treat ED.
This undeclared ingredient may interact with nitrates
found in some prescription drugs such as nitroglycerin and
may lower blood pressure to dangerous levels. Men with
diabetes, high blood pressure, high cholesterol, or heart
disease often take nitrates.
S.W.A.G. is promoted and sold on various websites and in
some retail stores.
For informational purposes only, consult a physician for any drug changes.
“FDA” stands for the United States Food and Drug Administration.
Even with FDA approval, drug availability depends on each manufacturer.
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Consumers should stop using this product immediately and
throw it away. Consumers who have experienced any negative side effects should consult a health care professional as
soon as possible. (4/18/14)
Zi Xiu Tang Bee Pollen Capsules Warning form
FDA: The FDA is warning consumers to immediately stop
using Zi Xiu Tang Bee Pollen, marketed as a product for
weight loss and body reshaping. The product contains at
least one potentially harmful active pharmaceutical ingredient that is not listed on the product’s label.
The FDA has tested multiple Zi Xiu Tang Bee Pollen products from various distributors in the United States. All
products that have been tested, including those that claim
to be “genuine” and “anti-counterfeit,” have been found to
contain one or both of the following undeclared drug ingredients:
• Sibutramine – a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because
sibutramine is known to substantially increase blood
pressure and/or pulse rate in some patients and may
present a significant risk for patients with a history of
coronary artery disease, congestive heart failure, arrhythmias or stroke.
• Phenolphthalein – a chemical that is not an active ingredient in any approved drug in the United States.
Studies have indicated that it presents a cancer-causing
risk.
The FDA has received dozens of adverse event reports, including many serious cardiac issues, associated with the
use of Zi Xiu Tang Bee Pollen. Reports have included heart
palpitations, tachycardia (increased heart rate), suicidal
thoughts, chest pain, diarrhea, anxiety, insomnia, increased blood pressure and seizure. Consumers who have
experienced any negative side effects while taking this
product should consult a health care professional.
Zi Xiu Tang Bee Pollen is manufactured by Guangzhou Zi
Xiu Tang Biotechnology Co., Ltd. in Guangdong Province,
China. It is offered for sale on the Internet, and it can be
found in various retail stores, spas and fitness centers. In
addition, licensed health care professionals have promoted
the product.
The FDA is investigating the distribution of Zi Xiu Tang
Bee Pollen products in the United States and may issue
warning letters or take enforcement action, such as seizures, injunctions and/or criminal charges. (4/8/14)
Revatio Pediatric Use Warning: The FDA is clarifying
its previous recommendation related to prescribing Revatio
(sildenafil) for children with pulmonary arterial hypertension (PAH). Revatio is FDA-approved only to treat PAH in
adults, not in children; however, health care professionals
must consider whether the benefits of treatment with the
drug are likely to outweigh its potential risks for each patient.
FDA revised the Revatio drug label in August 2012, adding
a warning stating that “use of Revatio, particularly chronic
use, is not recommended in children.” This recommendation was based on an observation of increasing mortality
with increasing Revatio doses in a long-term clinical trial in
pediatric patients with PAH. FDA issued a Drug Safety
Communication at that time. There may be situations in
which the benefit-risk profile of Revatio may be acceptable
in individual children, for example, when other treatment
options are limited and Revatio can be used with close
monitoring.
The purpose of the August 2012 recommendation was to
raise awareness of clinical trial results showing a higher
risk of mortality in pediatric patients taking a high dose of
Revatio when compared to pediatric patients taking a low
dose. This recommendation was not intended to suggest
that Revatio should never be used in children; however,
some health care professionals have interpreted this information as a contraindication, and have refused to prescribe
or administer the drug.
The evidence behind FDAs initial recommendation has not
changed; this communication is clarifying the strength of
the warning communicated in the Revatio drug label.
(3/31/14)
Recalls/Suspensions
Any adverse events that may be related to the use of these products should be
reported to the FDA's MedWatch Adverse Event Reporting Program (contact
information located at the end of the bulletin).
African Black Ant, Black Ant, and Mojo Risen
Products: Eugene Oregon, Inc. is voluntarily conducting
this recall because FDA analysis of these products distributed to a third party revealed that the distributed products
contained undeclared amounts of the active pharmaceutical ingredients sildenafil and tadalafil—FDA-approved
pharmaceutical ingredients used to treat ED. Conclusive
testing has not been done to confirm that the recalled
products do, in fact, contain sildenafil and/or tadalafil and
this recall is being executed as a precautionary measure.
Sildenafil and tadalafil can pose a threat to consumers because they can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure. Nitrates are found in prescription
drugs used to treat diabetes, high blood pressure, high cholesterol, and heart disease. Sildenafil and tadalafil can also
cause side effects such as headaches and flushing.
Eugene Oregon, Inc. has discontinued the distribution of
these products and is notifying its distributors by mail of
this voluntary recall.
Consumers that possess these products should stop using
them immediately and can return the products to Eugene
Oregon, Inc., 922 S. Woodbourne Rd. #304, Levittown, PA
19057-1001. Consumers should contact their physician or
healthcare provider if they have experienced any problems
that may be related to using these products. Consumers
with questions regarding this recall can contact Eugene
Oregon, Inc. by telephone at 1-800-538-3411 from Monday
through Friday between 9:00 a.m. and 5:00 p.m. EST.
(5/6/14)
Nova Products, Inc.—Dietary Supplements: Nova
Products, Inc. issued a voluntary recall of the following
products: African Black Ant (Lot# 2006-000926), Black
Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL),
For informational purposes only, consult a physician for any drug changes.
“FDA” stands for the United States Food and Drug Administration.
Even with FDA approval, drug availability depends on each manufacturer.
3
ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot#
13051012), XZone Gold (Lot# 131110GL), and XZone 1200
(Lot# 13071012) at the retail level. The FDA laboratory
analysis on these products has determined that they contain undeclared amounts of sildenafil and tadalafil, active
ingredients of FDA-approved drugs used to treat ED. These
undeclared active ingredients pose a threat to consumers
because they can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure. Prescription drugs containing nitrates are frequently prescribed for individuals with diabetes, high blood pressure, high cholesterol, or heart disease.
Additionally, these products may cause side effects such as
headaches and flushing.
These products are marketed as dietary supplements for
sexual enhancement and packaged in blister packs, envelopes, bottles, and/or boxes distributed to consumers nationwide at retail stores. Lot numbers are identified on the
back or side of each product.
Consumers that possess these products should stop using
them immediately and return the products to Nova Products, Inc., 5 Mount Pleasant Road, Aston, Pennsylvania.
Consumers with questions regarding this recall can contact
Nova Products, Inc. by telephone at 610-459-7709 between
9:00 a.m. and 5:00 p.m. EST. Consumers should contact
their physician or healthcare provider if they have experienced any problems that may be related to taking or using
these products. (3/31/14)
Bella Vi Brand Products by Pure Edge Nutrition:
Pure Edge Nutrition, LLC is voluntarily recalling one lot of
each: Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim
Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme
Accelerator, Bella Vi Insane Amp’d, and two lots of Bella Vi
Amp’d Up, to the consumer level. The FDA laboratory
analyses found the products to contain undeclared
sibutramine or a combination of both sibutramine and
phenolphthalein. Sibutramine was removed from the US
market in October 2010 for safety reasons and
phenophthalein is used as a laxative and not approved for
marketing in the US. Therefore, these products are
unapproved new drugs.
Products containing sibutramine and phenophthalein pose
a threat to consumers because sibutramine can increase
blood pressure and/or pulse rate in some patients and may
present a risk for those with a history of coronary artery
disease, congestive heart failure, arrhythmias, or stroke.
These products may also interact in life threatening ways
with other medications a consumer may be taking.
All affected products are marketed as dietary supplements
for weight loss.
Pure Edge Nutrition, LLC is notifying its distributors and
customers by email and is arranging for return of all
recalled products. Consumers and distributors that have
product which is being recalled should stop using and
return products to Pure Edge Nutrition, LLC. Consumers
with questions regarding this recall can contact Pure Edge
Nutrition, LLC at (888) 417-3613 Monday – Friday 10:00
a.m. – 2:00 p.m. EST or email info@pureedgenutrition.
com. (3/26/14)
New Life Nutritional Dietary Supplements: New
Life Nutritional Center is recalling all lots of “Super Fat
Burner capsules, Maxi Gold capsules and Esmeralda
softgels” to the user level after FDA analysis revealed the
products contain undeclared active pharmaceutical ingredients: sibutramine, phenolphthalein, or a combination of
both sibutramine and phenolphthalein.
Sibutramine is an appetite suppressant that was withdrawn
from the U.S. market in October 2010 (due to increased
risk of seizures, heart attacks, arrhythmias, and strokes).
Phenolphthalein is an ingredient previously used in overthe-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the
United States. These undeclared ingredients make these
products unapproved new drugs for which safety and efficacy have not been established.
These products are used as weight loss aids and are packaged in 30 capsule bottles. New Life Nutritional Center distributed these products to customers residing in NY, NJ,
LA, TX, VA, and MA via retail stores and internet sales
through their website at www.newlifenutritional.com.
New Life Nutritional Center is notifying its customers by
letter. Customers are advised to immediately discontinue
use of these products and should return the products immediately to New Life Nutritional Center 714 West 181st
Street NY, NY 10033 for a refund. (3/26/14)
Approved Drugs
Please access www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
for in-depth drug approval information.
Sivextro Approved by FDA to Treat Skin Infections:
The FDA today approved Sivextro (tedizolid phosphate), a
new antibacterial drug, to treat adults with skin infections.
Sivextro is approved to treat patients with acute bacterial
skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus
(including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species,
and Enterococcus faecalis. Sivextro is available for intravenous and oral use.
Sivextro is the second new antibacterial drug approved by
the FDA in the past month to treat ABSSSI. On May 23, the
agency approved Dalvance (dalbavancin), also to treat patients with ABSSSI caused by Staphylococcus aureus and
various Streptococcus species.
Sivextro’s safety and efficacy were evaluated in two clinical
trials with 1,315 adults with ABSSSI. Participants were randomly assigned to receive Sivextro or linezolid, another
antibacterial drug approved to treat ABSSSI. Results
showed Sivextro was as effective as linezolid for the treatment of ABSSSI. The most common side effects identified
in the clinical trials were nausea, headache, diarrhea, vomiting and dizziness. The safety and efficacy of Sivextro have
not been evaluated in patients with decreased levels of
white blood cells (neutropenia), so alternative therapies
should be considered.
Sivextro is marketed by Cubist Pharmaceuticals, based in
Lexington, Massachusetts. (6/23/14)
For informational purposes only, consult a physician for any drug changes.
“FDA” stands for the United States Food and Drug Administration.
Even with FDA approval, drug availability depends on each manufacturer.
4
Zontivity: The FDA approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular
death, and need for procedures to restore the blood flow to
the heart in patients with a previous heart attack or blockages in the arteries to the legs.
Zontivity is the first in a new class of drug, called a protease-activated receptor-1 (PAR-1) antagonist. It is an antiplatelet agent, designed to decrease the tendency of platelets to clump together to form a blood clot. By decreasing
the formation of blood clots, Zontivity decreases the risk of
heart attack and stroke.
Like other drugs that inhibit blood clotting, Zontivity increases the risk of bleeding, including life-threatening and
fatal bleeding. Bleeding is the most commonly reported
adverse reaction in people taking Zontivity. The drug’s prescribing information (label) includes a Boxed Warning to
alert health care professionals about this risk.
Zontivity must not be used in people who have had a
stroke, transient ischemic attack, or bleeding in the head,
because the risk of bleeding in the head is too great.
Patients should report to their health care professional any
unanticipated, prolonged or excessive bleeding, or blood in
their stool or urine. Zontivity will be dispensed with an
FDA-approved patient Medication Guide that provides instructions for its use and important safety information.
Zontivity is made by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. of Whitehouse Station, N.J.
(5/8/14)
Epanova: Epanova, generic name omega-3-carboxylic
acids, has been approved by the FDA. Epanova is indicated
as an adjunct to diet to treat severe hypertriglyceridemia in
adult patients. Severe hypertriglyceridemia is defined as
triglyceride levels of greater than or equal to 500mg/dL.
Epanova is manufactured by AstraZeneca and is available
in capsule form. (5/7/14)
Incruse Ellipta: The FDA has approved GlaxoSmithKline’s Incruse Ellipta (umeclidinium) once-daily inhalation powder for the treatment of long-term maintenance of
airflow obstruction in patients diagnosed with chronic obstructive pulmonary disease (COPD); also including chronic bronchitis and/or emphysema. GlaxoSmithKline anticipates a fourth quarter 2014 launch of Incruse Ellipta.
(5/1/14)
Cyramza for Stomach Cancer: The FDA approved
Cyramza (ramucirumab) to treat patients with advanced
stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the
esophagus joins the stomach.
Stomach cancer forms in the tissues lining the stomach and
mostly affects older adults. According to the National Cancer Institute, an estimated 22,220 Americans will be diagnosed with stomach cancer and 10,990 will die from the
disease, this year.
Cyramza is an angiogenesis inhibitor that blocks the blood
supply to tumors. It is intended for patients whose cancer
cannot be surgically removed (unresectable) or has spread
(metastatic) after being treated with a fluoropyrimidine- or
platinum-containing therapy.
Common side effects experienced by Cyramza-treated participants during clinical testing include diarrhea and high
blood pressure.
The FDA reviewed Cyramza under its priority review program, which provides an expedited review for drugs that
have the potential, at the time the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition. Cyramza was
also granted orphan product designation because it is intended to treat a rare disease or condition.
Cyramza is marketed by Indianapolis-based Eli Lilly.
(4/22/14)
Ragwitek for Short Ragweed Pollen Allergies: The
FDA approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or
without conjunctivitis (eye inflammation), in adults 18
years through 65 years of age.
Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once
daily by placing it sublingually, where it rapidly dissolves.
Treatment with Ragwitek is started 12 weeks before the
start of ragweed pollen season and continued throughout
the season. The first dose is taken in a health care professional’s office where the patient is to be observed for at
least 30 minutes for potential adverse reactions. After the
first dose, patients can take Ragwitek at home.
Individuals with allergic rhinitis with or without conjunctivitis may experience a runny nose, repetitive sneezing, nasal itching, nasal congestion, and itchy and watery eyes.
Short ragweed pollen is one of the most common seasonal
allergens and is prevalent during the late summer and early
fall months in most of the United States. Short ragweed
pollen induced allergies are generally managed by avoiding
the allergen, medications to relieve symptoms, or with allergy shots.
The Prescribing Information includes a boxed warning to
inform that severe allergic reactions, some of which can be
life-threatening, can occur. Ragwitek also has a Medication
Guide for distribution to the patient.
Ragwitek is manufactured for Merck, Sharp & Dohme
Corp., (a subsidiary of Merck and Co., Inc., Whitehouse
Station, N.J.) by Catalent Pharma Solutions Limited, United Kingdom. (4/18/14)
Tanzeum Injection: The FDA today approved Tanzeum
(albiglutide) subcutaneous injection to improve glycemic
control, along with diet and exercise, in adults with type 2
diabetes.
Type 2 diabetes affects approximately 24 million people
and accounts for more than 90 percent of diabetes cases
diagnosed in the United States. Over time, high blood sugar
levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney
damage.
Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels.
Tanzeum should not be used to treat people with type 1
diabetes; those who have increased ketones in their blood
For informational purposes only, consult a physician for any drug changes.
“FDA” stands for the United States Food and Drug Administration.
Even with FDA approval, drug availability depends on each manufacturer.
5
or urine (diabetic ketoacidosis); or as first-line therapy for
patients who can’t be managed with diet and exercise.
Tanzeum has a Boxed Warning to warn that tumors of the
thyroid gland (thyroid C-cell tumors) have been observed
in rodent studies with some GLP-1 receptor agonists, but
that it is unknown whether Tanzeum causes thyroid C-cell
tumors, including a type of thyroid cancer called medullary
thyroid carcinoma (MTC), in humans. Tanzeum should not
be used in patients with a personal or family history of
MTC or in patients with Multiple Endocrine Neoplasia
syndrome type 2 (a disease where patients have tumors in
more than one gland in their body and that predisposes
them to MTC).
The FDA approved Tanzeum with a Risk Evaluation and
Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with Tanzeum. (4/16/14)
Otezla: The FDA approved Otezla (apremilast) to treat
adults with active psoriatic arthritis (PsA).
PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint pain, stiffness, and swelling are
the main signs and symptoms of PsA. Currently approved
treatments for PsA include corticosteroids, tumor necrosis
factor (TNF) blockers, and an interleukin-12/interleukin23 inhibitor.
The FDA is requiring a pregnancy exposure registry as a
post-marketing requirement to assess the risks to pregnant
women related to Otezla exposure.
In clinical trials, the most common side effects observed in
patients treated with Otezla were diarrhea, nausea, and
headache.
Otezla is manufactured for Celgene Corporation, Summit,
N.J. (3/21/14)
New Generics
Generic Celebrex Approved: The FDA approved the
first generic versions of Celebrex (celecoxib) capsules, a
treatment for rheumatoid arthritis, osteoarthritis, shortterm (acute) pain, and other conditions.
Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram (mg), 100 mg, 200
mg, and 400 mg strengths, and has 180-day exclusivity on
the 100 mg, 200 mg, and 400 mg strength products. Mylan
Pharmaceuticals, Inc. received approval to market 50 mg
celecoxib capsules.
Celecoxib is a non-steroidal anti-inflammatory drug
(NSAID). All NSAIDs have a Boxed Warning in their prescribing information (label) to alert health care professionals and patients about the risk of heart attack or stroke that
can lead to death. This chance increases for people with
heart disease or risk factors for it, such as high blood pressure, or taking NSAIDs for long periods of time. The Boxed
Warning also highlights the risk of serious, potential lifethreatening GI bleeding that has been associated with use
of NSAIDs. (5/30/14)
FDA Approves Generic Vesicare: The FDA approved
the generic equivalent of Vesicare, solifenacin succinate,
used for the treatment of overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence.
Solifenacin succinate is manufactured by Teva Pharmaceuticals and is available as a 5mg and 10mg tablet. (4/20/14)
Generic Lunesta Approved: Mylan Inc. today announced that it has launched Eszopiclone Tablets 1 mg, 2
mg and 3 mg, the generic version of Sunovion Pharmaceuticals Inc.'s Lunesta. Mylan received final approval from
the FDA for its Abbreviated New Drug Application (ANDA)
for this product, which is indicated for the treatment of
insomnia. (4/16/14)
Approval of Generic Lovaza by Teva: Teva Pharmaceutical Industries Ltd. announced the approval of the generic equivalent to Lovaza (omega-3-acid ethyl esters capsules, USP), in the United States. Omega-3-acid ethyl esters
is available as 1 gram oral capsules containing at least
900mg of the ethyl esters of omega-3 fatty acids. Omega3-acid ethyl esters are used as adjunct to diet therapy in the
treatment of hypertriglyceridemia (triglycerides ≥ 500
mg/dL). Teva plans to commence shipping immediately.
(4/10/14)
Generic Mepron Suspension Approval: The generic
of brand name Mepron, atovaquone, was approved by the
FDA
for
patients
intolerant
to
trimethoprimsulfamethoxazole (TMP-SMZ) to prevent pneumocystis
carinii pneumonia (PCP). This drug is also approved in
patients intolerant to TMP-SMZ for short-term oral
treatment of mild to moderate PCP. Atovaquone is
manufactured by Amneal Pharmaceuticals and is available
as a 750mg/5mL oral suspension. (3/24/14)
New Indications
Reyataz—Expanded Indication and New Dosage
Form: The FDA has approved an expanded indication for
Reyataz (atazanavir) to include pediatric patients at least 3
months of age who weigh at least 10 kg for the treatment of
HIV-1 infection in combination with other antiretroviral
agents. Previously, Reyataz was only indicated for the
treatment of adults and pediatrics at least 6 years of age.
Additionally, the FDA has approved a new oral powder
dosage form for use in treatment-naive or treatmentexperienced pediatric patients who are at least 3 months of
age and weigh between 10 kg and less than 25 kg. (6/4/14)
Expanded Indication for Arzerra: The FDA has approved an expanded indication for GlaxoSmithKline’s
Arzerra (ofatumumab). This expanded indication now includes the treatment of previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil
in those who are unable to take fludarabine. Arzerra is also
indicated for the treatment of those with CLL refractory to
fludarabine and alemtuzumab. (4/22/14)
For informational purposes only, consult a physician for any drug changes.
“FDA” stands for the United States Food and Drug Administration.
Even with FDA approval, drug availability depends on each manufacturer.
6
Expanded Indication for Pradaxa: The FDA has approved an expanded indication for Boehringer Ingelheim’s
Pradaxa (dabigatran etexilate) capsules to include the
treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with
an injectable anticoagulant for 5 to 10 days, and to reduce
the risk of recurrent DVT and PE in patients who have been
previously treated. Pradaxa is also indicated for the prevention of stroke and systemic embolism in patients with
nonvalvular atrial fibrillation. Pradaxa labeling now also
includes an updated Boxed Warning regarding the risk of
spinal/epidural hematoma in patients receiving neuraxial
anesthesia or undergoing spinal puncture, in addition to
the existing warning that premature discontinuation increases the risk of thrombotic events. Pradaxa is dispensed
with a patient Medication Guide. (4/8/14)
Kalbitor Expanded Indication: The FDA has approved
an expanded indication for Dyax’s Kalbitor (ecallantide) to
include the treatment of acute attacks of hereditary angioedema in patients 12 years of age and older. Kalbitor was
previously approved for treatment in patients16 years of
age and older. The prescribing information for Kalbitor
includes a Boxed Warning regarding the risk of anaphylaxis
and it is dispensed with a patient Medication Guide.
(4/7/14)
Indication for Baraclude Expanded by the FDA:
Baraclude, known generically as entecavir, has been
approved by the FDA for use in children who have the
chronic hepatitis B virus with active viral replication and
evidence of either persistent elevations in serum
aminotransferases or histologically active disease. Use in
children is approved for those who are two years or older.
Previously, this medication was only approved for use in
adult patients. Baraclude is manufactured by Bristol-Myers
Squibb. (3/26/14)
FDA Expands Xolair Indication: Xolair (omalizumab)
injection is now approved by the FDA to treat patients 12
years and older with chronic idiopathic urticaria who still
experience symptoms despite H1 antihistamine treatment.
This drug is also approved to treat moderate to severe
persistent asthma in patients 12 years and older who have a
positive skin test or in vitro reactivity to a perennial
aeroallergen and who still experience symptoms due to
inadequate control with inhaled corticosteroids. Xolair’s
label does contain a boxed warning stating the risk of
anaphylaxis after administration. (3/24/14)
Miscellaneous
Nexium 24HR Approved for OTC: The FDA approved
over-the-counter Nexium® 24HR (esomeprazole 20mg).
In 2012, Pfizer acquired exclusive global rights from AstraZeneca to market non-prescription Nexium®. Pfizer continue to work closely with AstraZeneca and retail partners
to make Nexium® 24HR available to consumers in the
U.S., with other markets in Europe expected to follow this
year. (3/28/14)
U.S. Food and Drug Administration’s
MedWatch Adverse Event Reporting Program
Please contact MedWatch to voluntarily report a serious
adverse event, product quality problem, product use error,
or therapeutic failure that you suspect is associated with the
use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. You can also report suspected
counterfeit medical products to the FDA through MedWatch.
_______________________________
To report a serious problem:
1-800-332-1088 (phone)
1-800-FDA-0178 (fax)
_______________________________
MedWatch online:
http://www.fda.gov/MedWatch/report.htm
_______________________________
By mail (use postage-paid FDA Form 3500):
MedWatch
5600 Fishers Lane
Rockville, MD 20857
FUTURE DRUG RELEASES
LISTED ON NEXT PAGE.
Revised Labeling/
Prescribing Information
Synera for Home Use: The FDA has approved a label
change that will allow patients to use Synera (lidocaine and
tetracaine) topical patch at home. Galan US’s Synera patch
is indicated for use in patients 3 years and older on intact
skin to provide local analgesia for superficial venous access
and superficial dermatological procedures. (6/4/14)
For informational purposes only, consult a physician for any drug changes.
“FDA” stands for the United States Food and Drug Administration.
Even with FDA approval, drug availability depends on each manufacturer.
7
NON-SPECIALTY
Non-Specialty Generic Drugs Pipeline
† indicates the medication has been approved but may or may not be available
* indicates the medication is anticipated to be filed with the FDA at the listed date
Brand
Name
Brand
Manufacturer
Route of
Administration
Indication(s) / Use
Estimated
Approval /
Market Date
Alocril
Allergan
Ophthalmic
Allergies
approved†
Avandamet
GlaxoSmithKline
Oral
Type 2 diabetes
approved†
Avandia
Celebrex
GlaxoSmithKline
Pfizer
Oral
Oral
Type 2 diabetes
Osteoarthritis, pain
approved†
approved†
Dibenzyline
Roxane
Oral
Pheochromocytoma
approved†
lamotrigine ODT
Lamictal
ODT
Actavis
Oral
Seizures
approved†
pregabalin
Lyrica
Pfizer
Oral
Diabetic peripheral neuropathy, postherpetic
neuralgia, seizures, fibromyalgia
approved†
Shionogi Pharma
Oral
Asthma, atopic dermatitis, allergic rhinitis
approved†
Roche
Oral
Cytomegalovirus
approved†
Nasonex
Schering
Nasal
Allergies
JUL 2014
Lumigan
Allergan
Ophthalmic
Glaucoma, ocular hypertension
AUG 2014
Renagel
Genzyme
Oral
chronic kidney disease (CKD)
SEP 2014
Exforge
Novartis
Oral
High blood pressure
OCT 2014
Exforge
HCT
Novartis
Oral
High blood pressure
OCT 2014
Intuniv
Actavis
Oral
Advicor
Asacol
Diovan
Abbott
Warner Chilcott
Novartis
Oral
Oral
Oral
Attention deficit hyperactivity
disorder (ADHD)
Cholesterol
Ulcerative colitis, proctitis
High blood pressure
Fosrenol
Shire
Oral
Hyperphosphatemia associated with CKD
2014
Invega
Loestrin
24 Fe
Nexium
Oxycontin
Restasis
Janssen
Oral
Schizophrenia
2014
Warner Chilcott
Oral
Birth control pill
2014
AstraZeneca
Purdue
Allergan
Oral
Oral
Ophthalmic
Gastroesophageal reflux disease, ulcers
Moderate to severe pain
Chronic dry eye
2014
2014
2014
Viracept
ViiV Healthcare
Oral
Antiretroviral
2014
Vivelle-Dot
Novartis
Transdermal
Symptoms of menopause
2014
Tarka
Abbott
Oral
High blood pressure
FEB 2015
Welchol
Abilify
Daiichi Sankyo
Otsuka
Oral
Oral
MAR 2015
APR 2015
aprepitant
Emend
Merck
Oral
oxybutynin
linezolid
ciprofloxacin/
hydrocortisone
gemifloxacin
aspirin/
dipyridamole
memantine tablet
Oxytrol
Zyvox
Watson
Pfizer
Transdermal
Oral
Cholesterol
Psychiatric conditions
Chemo-associated nausea & vomiting,
prevention of post-op nausea & vomiting
Overactive bladder
Bacterial infections
Cipro-HC
Bayer
Otic
Bacterial ear infections
JUN 2015
Factive
Cornerstone
Boehringer
Ingelheim
Forest
Oral
Antibiotic
JUN 2015
Oral
Stroke prevention
JUL 2015
Oral
Alzheimer’s disease
JUL 2015
Solvay
Topical
Hormone replacement
AUG 2015
Transdermal
ADHD
SEP 2015
Oral
Benign prostatic hyperplasia
4Q2015
Generic Name
nedocromil
metformin/
rosiglitazone
rosiglitazone
celecoxib
phenoxybenzamine
prednisolone
valganciclovir
mometasone
furoate
bimatoprost
sevelamer hydrochloride
amlodipine/
valsartan
amlodipine/
valsartan/HCTZ
guanfacine ER
tablets
lovastatin/niacin
mesalamine
valsartan
lanthanum
carbonate
paliperidone ER
ethinyl estradiol/
norethindrone
esomeprazole
oxycodone ER
cyclosporine
nelfinavir
mesylate
estradiol
transdermal patch
trandolapril/
verapamil
colesevelam tablet
aripiprazole
testosterone
Orapred
ODT
Valcyte
Aggrenox
Namenda
Androgel
1%
methylphenidate
Daytrana
dutasteride
Avodart
Noven Pharmaceuticals
GlaxoSmithKline
DEC 2014
2014
2014
2014
APR 2015
APR 2015
MAY 2015
8
dutasteride/
tamsulosin
mesalamine DR
Jalyn
GlaxoSmithKline
Oral
Benign prostatic hypertrophy
4Q2015
Asacol HD
Oral
Ulcerative colitis
NOV 2015
almotriptan
Axert
Oral
Migraine
NOV 2015
Oral
Migraine
NOV 2015
Ortho TriCyclen Lo
Patanol
Warner Chilcott
Ortho-McNeilJanssen
Endo Pharmaceuticals
Ortho Mcneil
Janssen
Alcon
Oral
Birth control pill
DEC 2015
Ophthalmic
Allergic conjunctivitis
DEC 2015
Glumetza
Santarus
Oral
Type 2 diabetes
FEB 2016
Enablex
Crestor
Nuvigil
Novartis
AstraZeneca
Teva
Oral
Oral
Oral
Overactive bladder
Cholesterol
Sleep disorders
MAR 2016
MAY 2016
JUN 2016
Ziana
Medicis
Topical
Acne
JUL 2016
GlaxoSmithKline
Inhalation
Asthma, chronic obstructive
pulmonary disease (COPD)
AUG 2016
GlaxoSmithKline
Inhalation
Asthma, COPD
AUG 2016
Lupin, Mylan
Gilead Sciences
Oral
Oral
Rosacea
Influenza
AUG 2016
AUG 2016
Azor
Daiich Sankyo
Oral
High blood pressure
OCT 2016
Benicar
Benicar
HCT
Seroquel
XR
Relpax
Sensipar
Zetia
Azilect
Daiichi Sankyo
Oral
High blood pressure
OCT 2016
Daiichi Sankyo
Oral
High blood pressure
OCT 2016
AstraZeneca
Oral
Antipsychotic
NOV 2016
Pfizer
Amgen
Merck
Teva
Oral
Oral
Oral
Oral
Migraines
Hyperparathyroidism, hypercalcemia
Cholesterol
Parkinson’s disease
DEC 2016
DEC 2016
DEC 2016
FEB 2017
frovatriptan succinate
norgestimate/
ethinyl estradiol
olopatadine
metformin hydrochloride ER
darifenacin
rosuvastatin
armodafinil
clindamycin/
tretinoin
fluticasone/
salmeterol
fluticasone
doxycycline
oseltamivir
olmesartan/
amlodipine
olmesartan
olmesartan/HCTZ
Frova
Advair
Diskus
Flovent
Diskus
Oracea
Tamiflu
quetiapine ER
tablet
eletriptan
cinacalcet tablet
ezetimibe
rasagiline
ezetimibe/
simvastatin
atomoxetine
tiagabine
Vytorin
Merck
Oral
Cholesterol
APR 2017
Strattera
Gabitril
Oral
Oral
ADHD
Epilepsy
MAY 2017
JUN 2017
sildenafil
Viagra
Oral
Erectile dysfunction
DEC 2017
vardenafil
testosterone gel
rosiglitazone/
glimepiride
rivastigmine
solution
alendronate/
cholecalciferol
Levitra
Fortesta
Lilly
Cephalon
Actavis, Amneal,
Apotex, Dr. Reddy’s, Hetero,
Macleods, Mylan,
Teva, Torrent
Teva
Actavis
Oral
Topical
Erectile dysfunction
Male hypogonadism
OCT 2018
NOV 2018
Avandaryl
GlaxoSmithKline
Oral
Type 2 diabetes
uncertain
Exelon
Novartis
Oral
Alzheimer’s disease, Parkinson’s disease
uncertain
Fosamax
Plus D
Merck
Oral
Osteoporosis
uncertain
Non-Specialty Brand Drugs Pipeline
TBA = to be announced
† indicates the medication has been approved but may or may not be available
* indicates the medication is anticipated to be filed with the FDA at the listed date
Drug Name
Manufacturer
Impavido (miltefosine)
Incruse Ellipta
(umeclidinium)
Jublia (efinaconazole)
Paladin
Glaxo
SmithKline
Kaken, Valeant
Chelsea Therapeutics
Northera (droxidopa)
Sivextro (tedizolid phosphate)
Trius
Route of Administration
Indication(s) / Use
Estimated
FDA Filing /
Approval /
Market Date
Oral
Treatment of leishmaniasis
approved†
Inhalation
Asthma, COPD
approved†
Topical
Distal lateral subungal onychomycosis
approved†
Oral
Neurogenic orthostatic hypotension
approved†
Oral
Acute bacterial skin infections,
skin structure infections
approved†
9
Zontivity (vorapaxar sulfate)
TBA (cariprazine)
Merck
Forest,
Gedeon Richter
Oral
Oral
Myocardial infarction
Schizophrenia, acute treatment of manic or
mixed episodes associated with bipolar I
disorder
Hypoactive sexual desire disorder
in premenopausal women
approved†
2Q – 3Q2014
Girosa (filbanserin)
Sprout
Oral
Striverdi Respimat
(olodaterol)
Targiniq ER
(oxycodone/naltrexone)
Boehringer
Ingelheim
Inhalation
COPD
3Q2014
Purdue
Oral
Management of chronic pain
3Q2014
Boehringer
Ingelheim,
Eli Lilly
Oral
Type 2 diabetes
3Q2014
Helsinn, Eisai
Oral
Chemotherapy-induced nausea & vomiting
3Q – 4Q2014
Anacor
Merck
Topical
Oral
Oncyhomycosis
Insomnia
JUL 2014
AUG 2014
Janssen
Oral
Type 2 diabetes
AUG 2014
Oral
Opioid-induced constipation
SEP 2014
SubQ
Type 2 diabetes
SEP – OCT 2014
Oral
Type 2 diabetes
4Q2014
Valeant
Topical
Acne
NOV 2014
Forest
Glaxo
SmithKline
Oral
Hypertension
DEC 2014
SubQ
Type 2 diabetes
2014
TBA (empagliflozin)
TBA
(palonosetron/netupitant)
TBA (tavaborole)
TBA (suvorexant)
Vokanamet
(canagliflozin/metformin)
Movantik (naloxegol)
Trulicity (dulaglutide)
Xigduo
(dapagliflozin/metformin)
Onexton (clindamycin/
benzoyl peroxide)
TBA (nebivolol/valsartan)
Eperzan, Syncria (albiglutide)
AstraZeneca,
Nektar
Eli Lilly
AstraZeneca,
Bristol Myers
Squibb
3Q2014
Lixar (lixivaptan)
Cornerstone
Oral
TBA
(omeprazole/aspirin DR)
Pozen
Oral
AL-60371
Alcon
Otic
TBA (ivabradine)
TBA (olodaterol/
tiotropium bromide)
Toctino (alitretinoin)
TBA (eluxadoline
dihydrochloride)
TBA (patiromer)
Amgen
Boehringer
Ingelheim
Basilea, Stiefel
Oral
Hyponatremia associated with heart failure,
syndrome of inappropriate
antidiuretic hormone
Prevention of cardio- and cerebro-vascular
events, reduce risk of gastric ulcers in patients at risk of aspirin-induced gastric ulcers
Otitis externa and media with
a tympanostomy tube
Chronic heart failure
Inhalation
COPD
2Q2014 (filing*)
Oral
2Q2014 (filing*)
Furiex
Oral
Relypsa
AstraZeneca,
Bristol Myers
Squibb
Forest,
Almirall
Melinta
Boehringer
Ingelheim,
Eli Lilly
Ardea Biosciences, AstraZeneca
Boehringer
Ingelheim,
Eli Lilly
Acadia, Biovail
Oral
Atopic dermatitis (eczema)
Diarrhea-predominant
irritable bowel syndrome
Hyperkalemia in patients with CKD
Oral
Type 2 diabetes
4Q2014 (filing*)
Inhalation
COPD
4Q2014 (filing*)
Oral
Uncomplicated gonorrhea
4Q2014 (filing*)
Oral
Type 2 diabetes
4Q2014 (filing*)
Oral
Hyperuricemia, gout
4Q2014 (filing*)
Oral
Type 2 diabetes
4Q2014 (filing*)
Oral
Parkinson’s disease psychosis
4Q2014 (filing*)
Novartis
Oral
Heart failure
4Q2014 (filing*)
Starpharma
Vaginal
Bacterial vaginosis
Osiris
Topical
Diabetic foot ulcers
Hatchtech
Cerecor
Topical
Oral
Head lice
Cough
4Q2014 (filing*)
4Q2014 – 2015
(filing*)
2014 (filing*)
2014 (filing*)
Saxadapa
(saxagliptin/dapagliflozin)
TBA (aclidinium
bromide/formoterol)
TBA (delafloxacin)
TBA
(empagliflozin/metformin IR)
TBA (lesinurad)
TBA (linagliptin/
metformin ER)
TBA (pimavanserin)
TBA (sacubitril/valsartan
trisodium hemipentahydrate)
Vivagel (astodrimer)
Grafix (cellular matrix
[wound healing])
Deovo (head lice treatment)
FP-01
2014
2014
2Q2014 (filing*)
2Q2014 (filing*)
3Q2014 (filing*)
3Q2014 (filing*)
10
Ionsys (fentanyl)
The Medicines
Company
Daiichi Sankyo
Scioderm
Orexo
Helsinn Therapeutics
Alexion
Otsuka,
Lundbeck
Amgen
Transdermal
Acute postoperative pain
2014 (filing*)
Oral
Topical
Sublingual
2014 (filing*)
2014 (filing*)
2014 (filing*)
SubQ
Stroke prevention in atrial fibrillation
Epidermolysis bullosa
Pain
Treatment of cachexia &
anorexia in cancer patients
Hypophosphotasia
Schizophrenia, adjunctive therapy for
major depressive disorder
Hypercholesterolemia
Charleston
Laboratories
Oral
Pain
2014 (filing*)
TBA (nitazoxanide)
Romark
Oral
TBA (odanacatib)
TBA (pradigastat)
TBA (rifabutin/amoxicillin/
undisclosed PPI)
Merck, Celera
Novartis
Lixiana (edoxaban tosylate)
SD-101
TBA (alfentanil)
TBA (anamorelin)
TBA (asfotase alfa)
TBA (brexpiprazole)
TBA (evolocumab)
TBA (hydrocodone CR/
acetaminophen/
promethazine)
Oral
SubQ
Oral
2014 (filing*)
2014 (filing*)
2014 (filing*)
2014 (filing*)
Oral
Oral
Acute uncomplicated influenza as monotherapy or in combination with oseltamivir
Osteoporosis
Familial chylomicronemia syndrome
2014 (filing*)
2014 (filing*)
RedHill
Oral
Helicobacter pylori infection
2014 (filing*)
TBA (rolapitant)
OPKO, Tesaro
Oral
TBA (uridine triacetate)
BTG, Wellstat
Oral
TBA (omarigliptin)
Merck
Dainippon
Sumitomo
Pharma, Eisai
Adamas, Forest
TBA (ranirestat)
Arimenda
(memantine/donepezil)
Prestalia (perindopril arginine/amlodipine
besylate)
Symplmed,
XOMA
2014 (filing*)
Oral
Prevention of chemotherapy-induced
nausea & vomiting
Accidental overexposure to fluorouracil (5FU) due to dosing errors or impaired clearance of 5-FU from the body
Type 2 diabetes
>2014 (filing*)
Oral
Diabetic peripheral neuropathy
>2014 (filing*)
Oral
Alzheimer’s dementia
JAN 2015
Oral
Hypertension
JAN 2015
JAN 2015
2014 (filing*)
2014 (filing*)
Savaysa (edoxaban tosylate)
Daiichi Sankyo
Oral
Stroke & systemic embolic events risk
reduction in non-valvular a-fib, deep vein
thrombosis, & prevention of venous
thromboembolism
TBA (safinamide)
Newron,
Zambon
Oral
Parkinson’s disease
MAY 2015
Lixilan
(insulin glargine/lixisenatide)
Sanofi
SubQ
Type 2 diabetes
4Q2015
Oral
Type 2 diabetes
1Q – 2Q2015
(filing*)
Topical
Diabetic foot ulcers
2Q2015 (filing*)
Oral
Type 2 diabetes
2Q2015 (filing*)
Oral
Opioid-induced constipation
Takeda
Oral
Type 2 diabetes
Anacor
GW Pharmaceuticals
Otsuka
NovaBay
Forest
Roche
Shire
Pearl Therapeutics, AstraZeneca
Shire
AB Science
Novartis
Topical
Psoriasis, atopic dermatitis
2Q2015 (filing*)
APR 2015 –
MAR 2016 (filing*)
2015 (filing*)
Oral
Cancer pain,
spasticity in multiple sclerosis (MS)
2015 (filing*)
Ophthalmic
Oral
Oral
Oral
Adenoviral conjunctivitis
Ventricular arrhythmia
Schizophrenia
Iron overload
2015 (filing*)
2015 (filing*)
2015 (filing*)
2015 (filing*)
Inhalation
COPD
2015 (filing*)
Ophthalmic
Oral
Oral
Dry eye
Alzheimer’s disease
Fragile X syndrome
2015 (filing*)
2015 (filing*)
2015 (filing*)
TBA
(empagliflozin/linagliptin)
TBA (aclerastide)
TBA (empagliflozin/
metformin ER)
TBA (bevenopran)
TBA (fasiglifam hemihydrates)
AN-2728
Sativex (nabiximols)
TBA (auriclosene)
Stedicor (azimilide)
TBA (bitopertin)
TBA (deferitazole)
TBA (glycopyrronium bromide/formoterol)
TBA (lifitegrast)
TBA (masitinib)
TBA (mavoglurant)
Boehringer
Ingelheim,
Eli Lilly
Derma Sciences
Boehringer
Ingelheim,
Eli Lilly
Cubist, Eli Lilly
11
TBA (obeticholic acid)
TBA (ozenoxacin)
TBA (rifabutin/
clarithromycin/clofazimine)
TBA (tolperisone CR)
TBA (zirconium silicate)
Intercept
Ferrer
Oral
Topical
Primary biliary cirrhosis
Skin & skin structure infections
2015 (filing*)
2015 (filing*)
RedHill
Oral
Crohn’s disease
2015 (filing*)
Oral
Neuromuscular spasm & spasticity
2015 (filing*)
Sanochemia,
Katama
ZS Pharma
Sanofi Aventis,
Zealand
Titan,
Braeburn
Oral
Hyperkalemia
2015 (filing*)
SubQ
Type 2 diabetes
2015 (re-filing*)
SubQ
Opioid dependence in adults
2015 (re-filing*)
Merck,
ALK-Abello
Oral
Rhinitis, asthma allergy symptoms caused by
house dust mites
2015 – 2016
(filing*)
PBT-2
Prana Biotechnology
Oral
Huntington’s disease
TBA (langlenatide)
Hanmi
SubQ
Type 2 diabetes
TBA (semaglutide)
Novo Nordisk
SubQ
Type 2 diabetes
TBA (anacetrapib)
Merck
Oral
Atherosclerosis, dyslipidemia,
hypercholesterolemia
2015 – 2016
(filing*)
2015 – 2016
(filing*)
2015 – 2016
(filing*)
2015 – 2017 (filing*)
Novo Nordisk
SubQ
Type 1 & type 2 diabetes
2016
Teva
Oral
Huntington’s disease
2016 (filing*)
Isis
SubQ
Dyslipidemia, hypercholesterolemia
2016 (filing*)
Reviva
NovaBay
Oral
Topical
2016 (filing*)
2016 (filing*)
Portola
Oral
Schizophrenia
Impetigo
Stroke prevention in atrial fibrillation
patients, prevention of venous
thromboembolic events after surgery
Oral
Levodopa-induced dyskinesia
2016 (filing*)
Oral
Oral
Oral
Oral
Oral
Oral
Endometriosis
Type 2 diabetes
Treatment of migraine
Type 2 diabetes
Clostridium difficile-associated diarrhea
Tardive dyskinesia
2016 (filing*)
2016 (filing*)
2016 (filing*)
2016 (filing*)
2016 (filing*)
2016 (filing*)
Oral
BPH & Erectile dysfunction
2016 (filing*)
Pharnext SAS
Oral
Charcot-Marie-Tooth disease type 1A
2016 – 2017 (filing*)
Novo Nordisk
SubQ
Type 2 diabetes
1Q2017 (filing*)
Novartis
Novartis
Novartis
Novartis
Novartis
Novartis, Cytos
Oral
Oral
Oral
Oral
Oral
SubQ
COPD
Obese hypogonadotropic hypogonadism
Clostridium difficile infection
Type 2 diabetes
Asthma
Alzheimer’s disease
>2017 (filing*)
>2017 (filing*)
>2017 (filing*)
>2017 (filing*)
>2017 (filing*)
>2017 (filing*)
Novartis
Inhalation
Asthma, COPD
>2017 (filing*)
Lyxumia (lixisenatide)
Probuphine
(buprenorphine)
Mitizax (allergy immunotherapy tablet
[dust mite])
Ryzodeg (insulin
degludec/insulin aspart)
Huntexil (pridopidine)
ISIS-APOCIIIRx,
ISIS-304801
RP-5063
TBA (auriclosene)
TBA (betrixaban)
TBA (dipraglurant)
TBA (elagolix)
TBA (ertugliflozin)
TBA (lasmiditan)
TBA (sotagliflozin)
TBA (surotomycin)
TBA (valbenazine)
Zydena (udenafil)
TBA (baclofen/
naltrexone/sorbitol)
Ideglira (insulin
degludec/liraglutide)
BCT-197
BGS-649
LFF-571
LIK-066
QAW-039
TBA (amilomotide)
TBA
(mometasone/indacaterol)
Addex Therapeutics
AbbVie
Merck, Pfizer
CoLucid
Lexicon
Cubist
Neurocrine
Warner
Chilcott
2016 (filing*)
Oral
Anemia associated with CKD
2018 (filing*)
CM-AT
Astellas,
AstraZeneca
Curemark
Oral
uncertain
Misopress (misoprostol)
Ferring
Vaginal
Autism
Decrease birthing time to vaginal delivery for
women who have an unfavorable cervix
TBA (roxadustat)
uncertain
12
Non-Specialty Brand Drugs Pipeline — New Formulations
TBA = to be announced
† indicates the medication has been approved but may or may not be available
* indicates the medication is anticipated to be filed with the FDA at the listed date
Drug Name
Afrezza (insulin human
[rDNA origin] inhalation
powder)
Bunavail
(buprenorphine/naltrexone)
Epanova (eicosapentaenoic
acid/docosahexaenoic acid)
Ximino (minocycline ER)
Zecuity (sumatriptan transdermal)
TBA (insulin glargine)
Lecette (desogestrel/
ethinyl estradiol)
TBA (indomethacin submicron)
Zalviso (sufentanil)
Alisade (fluticasone furoate)
Genvir (acyclovir)
Contrave (naltrexone/
bupropion ER)
TBA (budesonide)
TBA (rizatriptan)
Zerenex (ferric citrate coordination complex)
Natpara
(recombinant human
parathyroid hormone)
Rytary (carbidopa/ levodopa)
TBA (liraglutide)
Rasuvo (methotrexate)
Rextoro
(testosterone undecanoate)
TBA (sumatriptan intranasal)
CompleoTRT
(testosterone intranasal)
GeNOsyl MVG-2000 (nitric
oxide delivery system)
Humalog (insulin lispro)
Levadex (dihydroergotamine)
MoxDuo IR (morphine/oxycodone)
Plumiaz (diazepam)
TBA
(amphetamine polistirex)
TBA (granisetron SR)
TBA (norethindrone transdermal delivery system)
TBA (levetiracetam ER)
Anoheal (diltiazem)
Toujeo (insulin glargine)
Manufacturer
Route of Administration
Indication(s) / Use
Estimated
FDA Filing /
Approval /
Market Date
MannKind
Inhalation
Type 1 & type 2 diabetes
approved†
BioDelivery
Oral
Opioid dependence
approved†
Oral
High triglycerides
approved†
Oral
Moderate to severe acne
approved†
NuPathe
Transdermal
Migraine
approved†
Sanofi
SubQ
Type 1 & type 2 diabetes
3Q2014
Teva
Oral
Prevention of pregnancy
JUL 2014
Iroko
Oral
Pain
JUL 2014
AcelRx
Sublingual
Moderate-to-severe acute
pain in hospital setting
JUL 2014
Inhalation
Asthma
AUG 2014
Oral
Herpes simplex virus infection
AUG 2014
Oral
Weight loss
SEP 2014
Rectal
Mild to moderate ulcerative colitis
SEP 2014
Oral
Acute migraine
SEP 2014
Keryx, Panacor
Oral
Hyperphosphatemia in
end-stage renal disease
SEP 2014
NPS, Takeda
SubQ
Hypoparathyroidism
OCT 2014
Impax
Novo Nordisk
Medac
Clarus Therapeutics
OptiNose,
Avanir
Oral
SubQ
SubQ
Parkinson’s disease
Weight management
Rheumatoid arthritis, psoriasis
OCT 2014
OCT 2014
NOV 2014
Oral
Testosterone deficiency
NOV 2014
Nasal
Acute treatment of migraine
NOV 2014
Trimel
Nasal
Male hypogonadism
2014
GeNO
Inhalation
Hypoxic respiratory failure in neonate
2014
Eli Lilly
Map, Nektar,
Allergan
RxPharma,
Actavis
Acorda Therapeutics
Neos Therapeutics
AP Pharma
SubQ
Type 1 & Type 2 diabetes
2014
Inhalation
Migraine
2014
Oral
New oral formulation for
moderate to severe acute pain
2014
Nasal
Seizures
2014
Oral
ADHD
2014
SubQ
Chemotherapy-induced nausea & vomiting
2014
Actavis
Topical
Prevention of pregnancy
2014
Sun
Ventrus, SLA
Pharma
Sanofi
Oral
Epilepsy
2014
Topical
Pain associated with anal fissure
2Q2014 (filing*)
SubQ
Type 1 & type 2 diabetes
2Q2014 (filing*)
Omthera,
AstraZenca
Ranbaxy
GlaxoSmith
Kline
Flamel Technologies
Orexigen,
Takeda
Salix
RedHill
BioPharma,
IntelGenX
13
TBA (benzhydrocodone)
KemPharm
Oral
Abuse-deterrent treatment of
moderate to severe pain
3Q2014 (filing*)
Androxal
(enclomiphene citrate)
Spiriva Respimat
(tiotropium bromide)
Repros
Oral
Secondary hypogonadism
4Q2014 (filing*)
Boehringer
Ingelheim
Inhalation
COPD
4Q2014 (filing*)
Sustol (granisetron SR)
Heron
SubQ
Chemotherapy-induced nausea & vomiting
4Q2014
(re-filing*)
Novartis
Inhalation
Moderate to severe COPD
4Q2014 (filing*)
Oral
Abuse-deterrent treatment of chronic pain
4Q2014 (filing*)
Oral
Oral
Abuse-deterrent treatment of chronic pain
Abuse-deterrent treatment of chronic pain
Oral
Secondary amenorrhea
4Q2014 (filing*)
4Q2014 (filing*)
4Q2014 – 2015
(filing)
Vectura, Novartis
Inhalation
Asthma, COPD
4Q2014 – 2016
(filing*)
Biofrontera
Topical
Actinic keratosis
2014 (filing*)
TBA (glycopyrronium bromide/indacaterol)
TBA
(hydrocodone bitartrate ER)
TBA (morphine ER)
TBA (oxycodone ER)
TBA (progesterone)
Seebri Breezhaler
(glycopyrronium bromide
long-acting)
Ameluz (5-aminolevulinic
acid nanocolloidal)
Cephalon,
Teva
Egalet
Collegium
TherapeuticsM
D
Amiket (ketamine/amitriptyline)
EpiCept
Topical
Asacard
(acetylsalicylic acid)
Flamel,
NewHaven
Oral
Bromsite (bromfenac)
InSite Vision
Ophthalmic
CCP-01
Tris, Vernalis
Ventrus Biosciences, SLA
Pharma
Teva
Oral
Neuropathic pain associated with
chemotherapy-induced peripheral
neuropathy in patients previously treated
with taxane-based chemotherapy
Secondary prevention of
cardiovascular disease
Pain, swelling, & inflammation
associated with ocular surgery
Cough, cold
Topical
Pain associated with anal fissures
2014 (filing*)
Inhalation
2014 (filing*)
Salix
SubQ
Asthma
Opioid-induced constipation
in chronic pain
AstraZeneca
Inhalation
Asthma, COPD
2014 (filing*)
RedHill
Insys
Therapeuics
Oral
Hypertension, heart failure
2014 (filing*)
Oral
Chemotherapy-induced nausea & vomiting
2014 (filing*)
Dolizem (diltiazem)
Proair Spiromax (albuterol)
Relistor
(methylnaltrexone bromide)
Symbicort
(budesonide/formoterol)
TBA (carvedilol CR)
TBA (dronabinol)
Binge eating disorder
2014 (filing*)
Piethora
Lightlake
Therapeutics
TBA (ondansetron)
RedHill
Oral
TBA (tadalafil)
IntelGenX
GlaxoSmithKline,
theravance
TBA (cough/
cold therapy ER)
Visonac
(methyl aminoevulinate)
TBA (esketamine)
2014 (filing*)
Nasal
TBA (lidocaine/prilocaine)
Orfadin (nitisinone)
2014 (filing*)
2014 (filing*)
Oral
Vycavert (hydrocodone/
acetaminophen)
Zubsolv (buprenorphine/
naloxone)
Bema LA
(buprenorphine buccal)
Viviant (bazedoxifene)
2014 (filing*)
Topical
Vitra, Shield
TBA (vilanterol)
2014 (filing*)
Iron deficiency anemia associated with inflammatory bowel disease
Premature ejaculation
TBA (ferric trimaltol)
TBA (naloxone)
2014 (filing*)
2014 (filing*)
Oral
Prevention of nausea & vomiting
in cancer patients
Erectile dysfunction
2014 (filing*)
Inhalation
COPD
2014 (filing*)
Acura
Oral
Moderate to severe pain
2014 (filing*)
Orexis
Sublingual
Opioid dependence
2014 (filing*)
Oral
Moderate to severe chronic pain
Oral
Postmenopausal osteoporosis
2014 – 2015 (filing*)
2014 (re-filing*)
Oral
Hereditary tyrosinemia type 1
2014 (re-filing*)
Tris, Vernalis
Oral
Cough, cold
Photocure
Topical
Acne
Janssen
Nasal
Depression
BioDelivery,
Endo
Pfizer
Swedish Orphan
Biovitrum
2014 (filing*)
2014 – 2015 (filing*)
2014 – 2015 (filing*)
2014 – 2017 (filing*)
14
SubQ
Type 1 and type 2 diabetes
1Q2015
transdermal
Hemostasis during surgery
JAN 2015
Purdue
Oral
Abuse-deterrent treatment of chronic pain
FEB 2015
Remoxy (oxycodone controlled-release)
Pfizer, Pain
Therapeutics
Durect
Oral
Moderate to severe chronic pain
2015
Rayaldy, Replidea (calcifediol)
Cytochroma
Oral
Secondary hyperpara-thyroidism
associated with vitamin D insufficiency
in patients with CKD
1Q2015 (filing*)
Vagicap (estradiol)
TherapeuticsM
D
Vaginal
Postmenopausal vulvar & vaginal atrophy
3Q2015 (filing*)
TBA (hydrocodone/
acetaminophen ER)
Mallinckrodt
Oral
Abuse-deterrent treatment of chronic pain
TBA (ramelteon)
Takeda
Sublingual
Acute & maintenance therapy of
bipolar I disorder
TBA (amikacin)
Bayer, Nektar
Inhalation
Gram negative bacterial respiratory
tract infections
4Q2015 (filing*)
TBA (estradiol/progesterone)
TherapeuticsM
D
Oral
Menopause symptoms
4Q2015 (filing*)
Biodel
SubQ
AstraZeneca
Actavis
Watson,
Gedeon Richter
SLA Pharma,
Ventrus
Tarsa Therapeutics,
Unigene
NeurogesX
Highland
Therapeutics
Egalet
Cosmo
TBA (insulin peglispro)
FibroCaps (fibrinogen/thrombin)
TBA
(hydrocodone bitartrate ER)
BIOD-Stable Glucagon (premixed stable glucagon)
Bydureon (exenatide CR)
Delzicol (mesalamine DR)
Esmya (ulipristal acetate)
Incostop (phenylephrine)
Ostora (calcitonin/
recombinant salmon)
TBA (capsaicin)
TBA (methylphenidate ER)
Eli Lilly
The Medicines
Company
MAR – APR
2015 (filing*)
APR 2015 –
MAR 2016 (filing*)
SubQ
Oral
Hypoglycemia caused by insulin overdose
or congenital hyperinsulinism
Type 2 diabetes
Ulcerative colitis
2015 (filing*)
2015 (filing*)
Oral
Anemia associated with uterine leiomyomas
2015 (filing*)
Rectal
Fecal incontinence
2015 (filing*)
Oral
Postmenopausal osteoporosis
2015 (filing*)
Topical
Neuropathic pain
2015 (filing*)
Oral
ADHD
2015 (filing*)
Oral
Oral
Pain
Gastroenteritis
2015 (filing*)
2015 (filing*)
2015 (filing*)
TBA (oxycodone)
TBA (rifamycin SV MMX)
TBA
(testosterone undecanoate)
Tefina (testosterone)
Vibex QS T (testosterone)
Lipocine
Oral
Male hypogonadism
2015 (filing*)
M et P Pharma
Antares
Nasal
SubQ
Female sexual arousal disorder
Hypogonadism
Tresiba (insulin degludec)
Novo Nordisk
SubQ
Type 1 & type 2 diabetes
2015 (filing*)
2015 (filing*)
2015 – 2016
(re-filing*)
Twirla (ethinyl estradiol/levonorgestrel)
Agile Therapeutics
Sucampo,
Takeda
Cynapsus
BioDelivery
Intarcia Therapeutics
Transdermal
Prevention of pregnancy
2016
Oral
Chronic idiopathic constipation
2016 (filing*)
Sublingual
Topical
Parkinson’s disease
Painful diabetic neuropathy
2016 (filing*)
2016 (filing*)
SubQ
Type 2 diabetes
2016 (filing*)
KemPharma
Oral
Chronic pain
2016 (filing*)
Makindus
Ophthalmic
Stargardt’s disease
2017 (filing*)
KemPharma,
Monosol Rx
Oral
ADHD
2017 (filing*)
Winston
Topical
Osteoarthritis
uncertain
Amitiza (lubiprostone)
TBA (apomorphine)
TBA (clonidine)
TBA (exenatide SR)
TBA
(hydromorphone prodrug)
TBA
(echothiophate iodide)
TBA (methylphenidate
prodrug/ligand)
TBA (zucapsaicin/
ciscapsaicin)
15
SPECIALTY
Specialty Generic Drugs Pipeline
† indicates the medication has been approved but may or may not be available
* indicates the medication is anticipated to be filed with the FDA at the listed date
Generic Name
Brand
Name
Brand Manufacturer
Route of Administration
Indication(s) / Use
Estimated
Approval /
Market Date
glatiramer acetate
Copaxone
Injection
MS
1Q2015
entecavir
Baraclude
Oral
Hepatitis B
FEB 2015
efavirenz
Sustiva
Oral
Antiviral
MAR 2015
epinephrine
bexarotene
bosentan
imatinib
abacavir/
lamivudine
lamivudine/
abacavir/
zidovudine
lopinavir/
ritonavir
ritonavir
abiraterone acetate
Epipen
Targretin
Tracleer
Gleevec
Teva
Bristol Myers
Squibb
Bristol-Myers
Squibb
Mylan
Eisai
Actelion
Novartis
Injection
Oral, Topical
Oral
Oral
JUN 2015
JUL 2015
NOV 2015
FEB 2016
Epzicom
GlaxoSmithKline
Oral
Anaphylactic reactions
Cutaneous T-cell lymphoma
Pulmonary arterial hypertension
Cancers (CML, ALL, etc.)
Human immunodeficiency
virus (HIV) infection
Trizivir
ViiV Healthcare
Oral
HIV
MAR 2016
Kaletra
Abbott
Oral
Antiviral
DEC 2016
Norvir
Zytiga
Oral
Oral
HIV infection
Prostate cancer
DEC 2016
DEC 2016
atazanavir
Reyataz
Oral
Antiretroviral
JUL 2017
tadalafil
tenofovir
efavirenz/emtricitabine/
tenofovir
fentanyl
Adcirca
Viread
AbbVie
Janssen
Bristol-Myers
Squibb
Synthon
Gilead
Oral
Oral
Pulmonary arterial hypertension
Antiviral
NOV 2017
JAN 2018
Atripla
Gilead
Oral
Antiviral
AUG 2018
Fentora
Cephalon
Buccal
Breakthrough cancer pain
OCT 2018
Specialty Brand Drugs Pipeline
MAR 2016
TBA = to be announced
† indicates the medication has been approved but may or may not be available
* indicates the medication is anticipated to be filed with the FDA at the listed date
Drug Name
Manufacturer
Route of Administration
Cerdelga (eliglustat tartrate)
Genzyme
Oral
Gaucher disease type 1
Elonva (corifollitropin alfa)
Merck
SubQ
Infertility
TBA (ceritinib)
Novartis
Oral
TBA (idelalisib)
Gilead Sciences
Oral
TBA (dolutegravir/
lamivudine/abacavir)
Tybost (cobicistat)
Vitekta (elvitegravir)
Esbriet (pirfenidone)
Faridak (panobinostat)
Solorel (macimorelin acetate)
TBA (asunaprevir)
TBA (daclatasvir)
TBA (faldaprevir)
TBA (veruprevir/ritonavir/
ombitsavir/desabuvir)
GlaxoSmithKline,
Viiv, Shionogi
Gilead
Gilead Sciences
InterMune
Novartis
Aeterna
Zentaris
Bristol Myers
Squibb
Bristol Myers
Squibb
Boehringer
Ingelheim
Enanta, AbbVie
Indication(s) / Use
Anaplastic lymphoma kinase positive
(ALK+) metastatic
non-small cell lung cancer
Cancers (Chronic lympocytic leukemia
(CML), indolent Non-Hodgkin’s Lymphoma
Estimated
FDA Filing /
Approval /
Market Date
JUN 2014
JUN – JULY
2014
3Q – 4Q 2014
AUG – SEP 2014
Oral
HIV
OCT 2014
Oral
Oral
Oral
Oral
HIV
HIV
Idiopathic pulmonary fibrosis
Multiple myeloma
Growth hormone deficiency,
treatment of cachexia
OCT 2014
OCT 2014
NOV 2014
NOV 2014
Oral
Hepatitis C virus infection
DEC 2014
Oral
Hepatitis C virus infection
DEC 2014
Oral
Hepatitis C virus infection
DEC 2014
Oral
Hepatitis C virus infection
DEC 2014
Oral
NOV 2014
16
TBA (apremilast)
TBA (dasabuvir)
TBA (ombitasvir)
TBA (veruprevir)
TBA (veruprevir/ritonavir/
ombitasvir)
Celgene
AbbVie
AbbVie
AbbVie
Oral
Oral
Oral
Oral
Psoriatic arthritis
Hepatitis C
Hepatitis C virus infection
Hepatitis C virus infection
2Q2014 (filing*)
2Q2014 (filing*)
2Q2014 (filing*)
2Q2014 (filing*)
AbbVie
Oral
Hepatitis C virus infection
2Q2014 (filing*)
TBA (alisertib)
Takeda
Oral
Peripheral T-cell lymphoma
TBA (palbociclib)
Pfizer, Onyx
Oral
Metastatic breast cancer
Iressa (gefitinib)
AstraZeneca
Oral
Non-small cell lung cancer
TBA (apricitabine)
Avexa
Oral
Multidrug resistant HIV infection
SubQ
Severe uncontrolled refractory asthma
4Q2014 (filing*)
SubQ
Cholesterol
4Q2014 (filing*)
Bosatria (mepolizumab)
TBA (alirocumab)
GlaxoSmithKline
Regeneron,
Sanofi Aventis
TBA (lomibuvir)
Vertex
Oral
Hepatitis C virus infection
Cinquil (reslizumab)
TBA (acolbifene)
TBA (avatrombopag)
UCB
Endoceutics
Eisai
SubQ
Oral
Oral
TBA (cobimetinib)
Genentech
Oral
TBA (danoprevir)
TBA (drisapersen)
TBA (eteplirsen)
TBA (lenvatinib mesylate)
Roche
Prosensa
AVI BioPharma
Eisai
Oral
SubQ
-Oral
TBA (lumacaftor)
Vertex
Oral
TBA (lumacaftor/ivacaftor)
Vertex
Oral
Eosinophilic asthma
Breast Cancer
Immune thrombocytopenic purpura
In combination with Zelboraf
for metastatic melanoma
Hepatitis C virus infection
Duchenne muscular dystrophy (DMD)
Duschenne muscular dystrophy
Endometrial cancer, thyroid cancer
Cystic fibrosis homozygous for
F508del CFTR mutation
Cystic fibrosis homozygous for
F508del CFTR mutation
TBA (mericitabine)
TBA (migalastat)
TBA (sonidegib/erismodegib)
TBA (telatinib)
TBA (tildrakizumab)
TBA (deleobuvir)
Pharmasset,
Roche
Amicus Therapeutics, GlaxoSmithKline
Novartis
ACT Biotech,
Bayer
Merck
Boehringer
Ingelheim
2014 (filing*)
Oral
Advanced basal cell carcinoma
2014 (filing*)
Oral
Gastric cancer
2014 (filing*)
SubQ
Psoriasis
Oral
Hepatitis C virus infection
>2014 (filing*)
2014 – 2015
(filing*)
2014 – 2015
(filing*)
Eleison,Threshold Pharmaceuticals
IV
Pancreatic cancer
TBA (momelotinib)
Gilead Sciences
Oral
Myelofibrosis
TBA (gevokizumab)
Xoma
SubQ
Pyoderma gangrenosum,
non-infectious uveitis, Behcet’s disease
JNJ-56914845 (GSK2336805, GSK-805)
Janssen
Oral
Chronic hepatitis C
TBA (guselkumab)
Janssen
SubQ
Psoriasis, rheumatoid arthritis
SubQ
Rheumatoid arthritis, lupus nephritis
TBA (darunavir/cobicistat)
2014 (filing*)
Fabry disease
TBA (glufosfamide)
TBA (atazanavir/cobicistat)
2014 (filing*)
Oral
Anemia associated with CKD & cancer
TBA (secukinumab)
2014 (filing*)
2014 (filing*)
2014 (filing*)
2014 (filing*)
2014 (filing*)
SubQ
Vargatef (nintedanib)
2014 (filing*)
Hepatitis C virus infection
Hospira
Janssen,
GlaxoSmith
Klein
Boehringer
Ingelheim
Novartis
Bristol Myers
Squibb,
Gilead Sciences
Janssen, Gilead
4Q2014 –
1Q2015 (filing*)
2014 (filing*)
2014 (filing*)
2014 (filing*)
Oral
TBA
(erythropoietin biosimilar)
TBA (sirukumab)
APR 2014 –
MAR 2015 (filing*)
3Q2014 (filing*)
3Q2014
(re-filing*)
3Q-4Q 2014
(filing*)
2014 – 2015
(filing*)
2014 – 2015
(filing*)
2014 – 2016
(filing*)
2014 – 2017 (filing*)
2014 – 2017 (filing*)
2014 – 2017+
(filing*)
SubQ; IV
Idiopathic pulmonary fibrosis;
non-small cell lung cancer; ovary tumor
Moderate to severe plaque psoriasis
Oral
HIV
FEB 2015
Oral
HIV
FEB 2015
Oral
1Q2015 – 2016+
JAN 2015
17
Firdapse
(amifampridine phosphate)
TBA (daclatasvir/asunaprevi/
beclabuvir)
AZD-9291
CO-1686
Recentin (cediranib)
Bristol Myers
Squibb
AstraZeneca
Clovis, Celgene
AstraZeneca
Rydapt (midostaurin)
Novartis
TBA (beclabuvir)
TBA (brodalumab)
TBA (elbasvir)
TBA (grazoprevir)
TBA (ledipasvir)
TBA (sarilumab)
TBA (tasquinimod)
TBA (trifluridine/tipiracil)
Catalyst
Bristol Myers
Squibb
Amgen, AstraZeneca
Merck
Merck
Gilead Sciences
Sanofi Aventis,
Regeneron
Active Biotech,
Ipsen
Taiho Pharmaceutical
Oral
Lambert-Eaton myasthenic syndrome
1Q2015 (filing*)
Oral
Hepatitis C virus infection
1Q2015 (filing*)
Oral
Oral
Oral
Non-small cell lung cancer
Non-small cell lung cancer
Ovarian cancer
Acute myeloid leukemia,
aggressive systemic mastocytosis
2015 (filing*)
2015 (filing*)
2015 (filing*)
Oral
Hepatitis C virus infection
2015 (filing*)
SubQ
Moderate to severe plaque psoriasis
2015 (filing*)
Oral
Oral
Oral
Chronic hepatitis C
Chronic hepatitis C
Hepatitis C virus infection
Rheumatoid arthritis,
ankylosing spondylitis
2015 (filing*)
2015 (filing*)
2015 (filing*)
Oral
Metastatic castrate-resistant prostate cancer
2015 (filing*)
Oral
Metastatic colorectal cancer
2015 (filing*)
2015-2016 (filing*)
2015 – >2017
(filing*)
2Q2016 (filing*)
2Q2016 (filing*)
2Q2016 (filing*)
2016 (filing*)
2016 (filing*)
Oral
SubQ
TBA (romosozumab)
UCB, Amgen
SubQ
Bone loss disorders, including postmenopausal osteoporosis and bone fractures
TBA (buparlisib)
Novartis
Oral
Breast cancer & solid tumors
ACH-3102
TBA (sovaprevir)
TG-4010
LCI-699
LEE-011
Proellex-V
(telapristone acetate)
TBA (benralizumab)
TBA (binimetinib)
TBA
(binimetinib/encorafenib)
Achillion
Achillion
Transgene
Novartis
Novartis
Oral
Oral
SubQ
Oral
Oral
Repros
Oral
AstraZeneca
Novartis
SubQ
Oral
Chronic hepatitis C
Chronic hepatitis C
Non-small cell lung cancer
Cushing’s disease
Metastatic breast cancer
Severe menstrual bleeding associated
with uterine fibroids
Severe uncontrolled asthma
NRAS melanoma
Novartis
Oral
BRAF mutant melanoma
TBA (bococizumab)
Pfizer
SubQ
TBA (defactinib)
TBA (dovitinib)
TBA (encorafenib)
TBA (lebrikizumab)
Verastern
Novartis
Novartis
Genentech
Oral
Oral
Oral
SubQ
TBA (masitinib)
AB Science
Oral
TBA (mericitabine)
TBA (olaparib)
TBA (pacritinib)
TBA (setrobuvir)
TBA (venetoclax)
Translarna (ataluren)
Pharmasset,
Roche
AstraZeneca
Cell Therapeutics
Roche
AbbVie, Genentech, Roche
PTC Therapeutics
Hyperlipidemia, dyslipidemia, & heterozygous familial hypercholesterolemia
Mesothelioma
Renal cell cancer
BRAF mutant melanoma
Asthma
Rheumatoid arthritis, asthma, amyotrophic
lateral sclerosis, gastrointestinal stromal
tumor
2015 (filing*)
2015 (filing*)
2016 (filing*)
2016 (filing*)
2016 (filing*)
2016 (filing*)
2016 (filing*)
2016 (filing*)
2016 (filing*)
2016 (filing*)
2016 (filing*)
2016 (filing*)
Oral
Chronic hepatitis C
2016 (filing*)
Oral
BRCA-mutated ovarian cancer
2016 (filing*)
Oral
Myelofibrosis
2016 (filing*)
Oral
Hepatitis C virus infection
2016 (filing*)
Oral
Chronic lymphocytic leukemia
2016 (filing*)
Oral
Nonsense mutation duchenne muscular
dystrophy
Metastatic gastric or gastroesophageal junction cancer
TBA
(ipatasertib dihydrochloride)
Genentech
Oral
FSH-GEX, GT-GP 2.4 GEX
Glycotype
SubQ
Infertility
TBA (selumetinib)
BGJ-398
BYL-719
TBA (alisporivir)
TBA (dactolisib)
TBA (quilizumab)
TBA (siponimod)
AstraZeneca
Novartis
Novartis
Novartis
Novartis
Novartis
Novartis
Oral
Oral
Oral
Oral
Oral
SubQ
Oral
KRAS+ non-small cell lung cancer
Solid tumors
Solid tumors
Hepatitis C virus infection
Solid tumors
Allergic diseases
Secondary progressive MS
2016 (filing*)
>2016 (filing*)
2016 – 2017 (filing*)
2017 (filing*)
>2017 (filing*)
>2017 (filing*)
>2017 (filing*)
>2017 (filing*)
>2017 (filing*)
>2017 (filing*)
18
Specialty Brand Drugs Pipeline — New Formulations
TBA = to be announced
† indicates the medication has been approved but may or may not be available
* indicates the medication is anticipated to be filed with the FDA at the listed date
Manufacturer
Route of Administration
Indication(s) / Use
Estimated
FDA Filing /
Approval /
Market Date
Biogen Idec
SubQ
Relapsing forms of MS
AUG 2014
Baxter,
Halozyme
SubQ
Primary immunodeficiency in adults
SEP 2014
Xaluprine (mercaptopurine)
Nova, Rare
Disease Therapeutics
Oral
Acute lymphoblastic leukemia
4Q2014
Envarsus (tacrolimus)
Veloxis
Oral
Drug Name
Plegridy
(peginterferon beta-1a)
Hyqvia (immunoglobulin
[human]/hyaluronidase [human, recombinant])
TBA (sofosbuvir/ledipasvir)
Pharmacyclics,
Janssen
Gilead
Kalbitor (ecallantide)
Dyax
Imbruvica (ibrutinib)
TBA
(filgrastim biosimilar)
Lonquex (lipegfilgrastim)
TBA (treprostinil
diethanolamine)
TBA (daclizumab)
Pan Pharmaceuticals Harvest Moon
Pharmaceuticals
Teva
United Therapeutics
Biogen Idec,
AbbVie
Arikace
(amikacin liposomal)
Insmed,
Transave
Kalydeco (ivacaftor)
Vertex
Chiasma,
Roche
Ablynx
Gilead Sciences
Octreolin (ocreotide acetate)
TBA (caplacizumab)
TBA (tenofovir alafenamide)
Oral
Oral
SubQ
Improved tablet formulation for kidney
transplant rejection prevention
Chronic lymphocytic leukemia,
small lymphocytic leukemia
Hepatitis C virus infection
Concentrated formulation for
hereditary angioedema
OCT 2014
OCT 2014
OCT 2014
2014
SubQ
Neutropenia
2014
SubQ
Chemotherapy-induced neutropenia
2014
Oral
Pulmonary arterial hypertension
2014
SubQ
Relapsing remitting MS
4Q2014 (filing*)
Oral
Gram-negative lung infections caused by
pseudomonas aeruginosa in patients with
cystic fibrosis & bronchiectasis, nontuberculous mycobacteria lung infections
Cystic fibrosis
2014 (filing*)
Oral
Acromegaly
2014 (filing*)
SubQ
Thrombotic thrombocytopenic purpura
2014 (filing*)
Oral
HIV in treatment-naïve adults
1Q2015 (filing*)
Inhalation
Chronic pseudomonas aeruginosa lung infections in bronchiectasis
4Q2015 (filing*)
Inhalation
2014 (filing*)
TBA (ciprofloxacin dry powder inhalation)
BA-058, BIM-44058,
ITM-058
for LAR (pasireotide)
TBA (growth hormone)
TBA (peginterferon
lambda-1a)
Phenylase (phenylalanine
hydroxylase)
Redium
Health, Teijin
Novartis
Prolor Biotech
Bristol Myers
Squibb
SubQ
Postmenopausal osteoporosis
2015 (filing*)
SubQ
SubQ
Cushing’s syndrome
Growth hormone deficiency
Hepatitis B virus infection,
hepatitis C virus infection
2015 (filing*)
2015 (filing*)
BioMarin
SubQ
Phenylketonuria
1Q2016 (filing*)
TBA
(etanercept biosimilar)
Baxter,
Daiichi
Sankyo,
Coherus
SubQ
Rheumatoid arthritis
2016 (filing*)
Bayer, Nektar
SubQ
>2015 (filing*)
References:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Pharmacist’s Letter, Anticipated Availability of First-Time Generics, Therapeutic Research Center, 3120 W. March Lane, PO Box 8190, Stockton, CA 95208, Copyright © 1995-2014, All rights reserved, last accessed 3/25/2014,
http://pharmacistsletter.therapeuticresearch.com/pl/ArticleDD.aspx?nidchk=1&cs=&s=PL&dd=290111&pb=&pt=2&fpt=55&menu=ftg
Rx Outlook: Generic Pipeline December 2013-December 2016, SXC Drug Information Services, 2013 SXC Health Solutions, Inc. Volume 7, Issue 12, 4th Quarter 2013
Rx Outlook: Generic Pipeline June 2014 to June 2017, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 4, 2nd Quarter 2014
Rx Outlook: Generic Pipeline March 2014 to March 2017, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 1, 1st Quarter 2014
Rx Outlook: Non-specialty pipeline – Q1 2014 to 2018, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 2, 1st Quarter 2014
Rx Outlook: Non-specialty pipeline – Q4 2013 to 2017, Catamaran Inc. Drug Intelligence Services, 2013 Catamaran Inc. Volume 7, Issue 13, 4th Quarter 2013
Rx Outlook: Non-specialty pipeline – 2014 to 2017, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 5, 2nd Quarter 2014
Rx Outlook: Specialty pipeline – Q1 2014 to 2018, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 3, 1st Quarter 2014
Rx Outlook: Specialty pipeline – Q4 2013-2017, Catamaran Inc. Drug Intelligence Services, 2013 Catamaran Inc. Volume 7, Issue 13, 4th Quarter 2013
Rx Outlook: Specialty pipeline – 2014 to 2017, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 6, 2nd Quarter 2014
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