Download Eleventh Specialty Pharma Newsletter (December 2009)

Specialty Pharma Newsletter (January 2013)
Feb 11 Departments of Justice and Health and Human Services announce record-breaking recoveries
resulting from joint efforts to combat health care fraud. A new report was released today showing
that for every dollar spent on health care-related fraud and abuse investigations in the last three years, the
government recovered $7.90. This is being touted as the highest three-year average return on investment
in the 16-year history of the Health Care Fraud and Abuse (HCFAC) Program. The article made no
mention of how many billions of taxpayer money was actually lost due to fraud, only the portion
recovered ($14.9 billion).
Feb 8
Security Guard Fires Shots and Wounds 15 Year Old Boy at FDA Office in Bothell, Washington.
The FDA Laboratory, called the Pacific Regional Lab Northwest, analyzes samples of products for safety
and compliance with regulations. The teen is a student at the Secondary Academy for Success, an
alternative high school near the FDA building. The guard who fired the shots is under contract to Federal
Protective Service, a division of the Department of Homeland Security that provides security at federal
buildings. The boy was treated at a hospital for a gunshot wound to the foot. The teen was also involved
in a non-injury hit and run accident after fleeing from the lab’s parking lot. The FPS is working with local
law enforcement to investigate the incident.
Feb 8
FDA Approves Pomalyst for Advanced Multiple Myeloma. The U.S. Food and Drug Administration
today approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease
progressed after being treated with other cancer drugs.
Feb 7
Guidance for Industry: Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage
Disease. This guidance explains the FDA’s current thinking about the way researchers can identify and
select patients with early Alzheimer’s disease, or those who are at risk of developing the disease, for
participation in clinical trials. In recent years, the research community has tried to find ways to identify
these patients using criteria that are based on biological indicators (biomarkers). Researchers have also
tried to develop sensitive clinical measures that can detect subtle mental decline. You can view and save
this guidance at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM3382
87.pdf
Feb 7
FDA’s Efforts to Address the Misuse and Abuse of Opioids. The FDA has established a task force to
build upon existing initiatives and develop new ones. You can read more at:
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337852.htm?source=govdelivery
Feb 6
Recalls – Class I
Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count
bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 06033888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC
0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, manufactured for: Qualitest
Pharmaceuticals, Huntsville, AL 35811. Reason: Superpotent (Multiple Ingredient) Drug: Complaint
received of oversized tablets.
Feb 6
Recalls – Class II
Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration,
Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033. Reason:
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification
result in the degradation product testing detected during stability monitoring.
Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc.,
Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3. Reason: Failed
Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Feb 5
Drugs to be Discontinued
Doxycycline Hyclate (by Teva), Ephedrine Sulfate (by West-Ward Pharmaceutical), Flecainide Acetate
[Tambocor] (by Medics Pharmaceutical Corp), Orphenadrine Citrate [Norflex] (by Medicis
Pharmaceutical Corporation), and Rifampin/Isoniazid 300 mg Capsules (by West-Ward Pharmaceutical).
Feb 4
FDA Approval of Generic Version of Cancer Drug Doxil is Expected to Help Resolve Shortage. The
U.S. Food and Drug Administration today approved the first generic version of the cancer drug Doxil
(doxorubicin hydrochloride liposome injection). Doxorubicin hydrochloride liposome injection is
currently on the FDA’s drug shortage list. For products on the shortage list, the FDA’s Office of Generic
Drugs is using a priority review system to expedite the review of generic applications to help alleviate
shortages. The generic is made by Sun Pharma Global FZE (Sun). Doxorubicin hydrochloride liposome
injection is administered intravenously by a health care professional. Sun’s generic will be available in 20
milligram and 50 milligram vials.
Feb 3
Manual of Policies and Procedures: Applications for Parenteral Products in Plastic Immediate
Containers. You can download this policy at:
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/
ManualofPoliciesProcedures/UCM081999.pdf?source=govdelivery
Feb 1
Draft Guidance for Industry: S10 Photosafety Evaluation of Pharmaceuticals. To download go to:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM3375
72.pdf?source=govdelivery
Feb 1
Acetaminophen Toxicity White Paper. Although acetaminophen overdose is very rare in the context of
its broad usage, overdose can be toxic and lead to acute liver failure. Acetaminophen Best Practices Task
Group, which produced Version 1.0 of a White Paper and an update, “NCPDP Recommendations for
Improved Prescription Container Labels for Medicines Containing Acetaminophen, Version 1.1”. You
can download this document at:
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM266631.pdf?source=govdelivery
Feb 1
Guidance for Industry on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase
Clinical Studies and Recommendations for Labeling. This guidance is intended to assist the
pharmaceutical industry and other investigators engaged in new drug development in evaluating how
variations in the human genome, specifically DNA sequence variants, could affect a drug's
pharmacokinetics (PK), pharmacodynamics (PD), efficacy, or safety. The guidance provides
recommendations on when and how genomic principles should be considered and applied in early-phase
clinical studies to address questions arising during drug development and regulatory review. You can
download at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM3371
69.pdf?source=govdelivery
Jan 31
Guidance for Industry: Guidance Agenda: New & Revised Draft Guidance CDER is Planning to
Publish During Calendar Year 2013. Download at: http://www.fda.gov/ucm/groups/fdagovpublic/@fdagov-drugs-gen/documents/webcontent/ucm314767.pdf
Jan 30 Recalls – Class II
Lisinopril Tablets, USP 40 mg, Rx only, Manufactured by: West-ward Pharmaceutical Corp.,
Eatontown, NJ 07724. Reason: Presence of Foreign Substance: Uncharacteristic black spots identified as
a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been
found in the tablets.
Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg. Rx only, Manufactured by: West-ward
Pharmaceutical Corp., Eatontown, NJ 07724. Reason: Presence of Foreign Substance: Reports of gray
smudges identified as minute stainless steel particulates were found in the recalled tablets.
PredniSONE Tablets, USP, 20 mg, Rx only, Manufactured by: West-ward Pharmaceutical Corp.,
Eatontown, NJ 07724. Reason: Presence of Foreign Substance: A complaint was received for black
specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich
inclusions.
Propylthiouracil Tablets, USP, 50 mg, Rx only, Manufactured by: West-ward Pharmaceuticals Corp.
Eatontown, NJ 07724. Reason: Presence of Foreign Substance: Uncharacteristic spots identified as steel
corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.
Jan 29 FDA approves new orphan drug Kynamro to treat inherited cholesterol disorder. The U.S. Food and
Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipidlowering medications and diet to treat patients with a rare type of high cholesterol called homozygous
familial hypercholesterolemia (HoFH). The addition of Kynamro helps to reduce low-density lipoproteincholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol
(non HDL-C). HoFH, an inherited condition that affects about one out of every one million people in the
United States, occurs when the body is unable to remove LDL-C, often called “bad” cholesterol, from the
blood causing abnormally high levels of circulating LDL-C. For those with HoFH, heart attacks and death
often occur before age 30. Kynamro is an orphan drug approval, meaning it was developed to treat a
disorder affecting fewer than 200,000 people. In December 2012, the FDA approved Juxtapid (lomitapide)
to reduce LDL-C, total cholesterol, apolipoprotein B, and non HDL-C in patients with HoFH.
Jan 25
Guidance For Industry: Providing Regulatory Submissions in Electronic Format — Certain
Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
Specifications. This guidance provides, among other things, the requirements for a valid electronic
submission under section 745A (a) of the FD&C Act. In accordance with section 745A (a), following the
issuance of a final guidance on this topic, submission types identified in this draft guidance must be
submitted electronically (except for submissions that are exempted), in a format that FDA can process,
review and archive. Currently, the Agency can process, review and archive electronic submissions made
using the electronic common technical document (eCTD) specifications. Submissions that are not
submitted electronically and electronic submissions that are not in a format that FDA can process, review
and archive will not be filed, unless exempted from the electronic submission requirement. At the same
time, this document also provides guidance on FDA’s interpretation of the statutory electronic submission
requirement and the Agency’s current thinking on the best means for implementing other aspects of the
electronic submission program. Download at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM3339
69.pdf?source=govdelivery
Jan 25 Current Good Manufacturing Practice Requirements for Combination Products. FDA has issued a
regulation on the current good manufacturing practice (CGMP) requirements applicable to combination
products. This rule is intended to promote the public health by clarifying which CGMP requirements
apply when drugs, devices, and biological products are combined to create combination products. In
addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when
demonstrating compliance with CGMP requirements for “single-entity” and “co-packaged” combination
products. Read the Federal Register Notice at: http://www.gpo.gov/fdsys/pkg/FR-2013-01-22/pdf/201301068.pdf
Jan 25 Warning Letters
NX Generation Ltd., Hauppauge, NY 11788 – Issued to Mr. Michael S. Lewis, President
Current Good Manufacturing Practice (cGMP) violations for dietary supplements
Novo Nordisk A/S, Bagsvaerd, Denmark – Issued to Mr. Lars Rebien Sorensen, President
Current Good Manufacturing Practice (cGMP) violations for sterile products
Jan 23 FDA approves Exjade to remove excess iron in patients with genetic blood disorder. The U.S. Food
and Drug Administration today expanded the approved use of Exjade (deferasirox) to treat patients ages
10 years and older who have chronic iron overload resulting from a genetic blood disorder called nontransfusion-dependent thalassemia (NTDT).
Jan 17 Generic Drug User Fee Amendments (GDUFA) Facility Fees for 2013.
Domestic FDF facility: $175,389
Foreign FDF facility: $190,389
Domestic API facility: $26,458
Foreign API facility: $41,458
In FY 2013, fees will be due by March 4, 2013. Fees for FYs 2014 to 2017 will be due the first business
day on or after October 1 of each fiscal year. Any person that owns a facility that is identified or intended
to be identified in at least one generic drug submission that is pending or approved to produce one or more
generic drug FDFs and/or APIs is required to pay facility fees. For a more complete explanation, go to:
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm319566.htm?source=govdelivery
Jan 16 FDA Approves New Seasonal Influenza Vaccine Made Using Novel Technology. The U.S. Food and
Drug Administration today announced that it has approved Flublok, the first trivalent influenza vaccine
made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is
approved for the prevention of seasonal influenza in people 18 through 49 years of age.
Jan 15 FDA/CDER Small Business Chronicles. The topic of this month’s issue of the FDA/CDER Small
Business Chronicles is Breakthrough Therapies. In this issue, we discuss a new program to help expedite
the development of new drugs that could potentially offer a substantial improvement over existing
therapies for patients with serious or life-threatening diseases who are especially in need of new safe and
effective treatments. You can read/download a copy at:
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM3356
28.pdf?source=govdelivery
Previous newsletters are also archived on the webpage
at: http://www.fda.gov/cdersmallbusinesschronicles.
Jan 11
FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs;
FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien
CR, Edluar, and Zolpimist). The U.S. Food and Drug Administration (FDA) is notifying the public of
new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime
dose be lowered because new data show that blood levels in some patients may be high enough the
morning after use to impair activities that require alertness, including driving. Today’s announcement
focuses on zolpidem products approved for bedtime use, which are marketed as generics and under the
brand names Ambien, Ambien CR, Edluar, and Zolpimist. FDA has informed the manufacturers that the
recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release
products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products
(Ambien CR). FDA also informed the manufacturers that, for men, the labeling should recommend that
health care professionals consider prescribing the lower doses―5 mg for immediate-release products and
6.25 mg for extended-release products
Jan 9
Recalls – Class II
Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
26505 NDC 0378-2045-01. Reason: Failed USP Content Uniformity Requirements: OOS result reported
on retained samples.
Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC
0074-7069-90; Abbott Laboratories North Chicago, IL 60064 U.S.A. Reason: Labeling: Error on
Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Jan 9
FDA issues draft guidance on abuse-deterrent opioids. “The FDA is extremely concerned about the
inappropriate use of prescription opioids, which is a major public health challenge for our nation,” said
FDA Commissioner Margaret A. Hamburg, M.D. “This draft guidance is an important part of a larger
effort by FDA aimed at preventing prescription drug abuse and misuse.” You can download this
guidance at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM3347
43.pdf
Jan 7
FDA Issues Two New Guidance Documents.
Safety Reporting Requirements for INDs and BA/BE Studies. Download at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM2273
51.pdf?source=govdelivery
Safety Reporting Requirements for INDs and BA/BE Studies – Small Entity Compliance Guide.
Download at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM3328
46.pdf?source=govdelivery
Jan 4
Guidance for Industry.
CDER Guidance New/Revised/Withdrawn in 2102. You can see the list at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM2993
52.pdf?source=govdelivery
Dec 21 FDA Expands Tamiflu’s Use to Treat Children Younger than 1 Year. The U.S. Food and Drug
Administration today expanded the approved use of Tamiflu (oseltamivir) to treat children as young as 2
weeks old who have shown symptoms of flu for no longer than two days. The drug is not approved to
prevent flu infection in this population. In addition, the safety and efficacy of Tamiflu to treat flu infection
has not been established in children younger than 2 weeks old. Tamiflu was approved in 1999 to treat
adults infected with flu who have shown symptoms for no longer than two days. It has since been
approved to treat flu in children ages 1 year and older who have shown symptoms of flu for no longer than
two days, and to prevent flu in adults and children ages 1 year and older. Although there is a fixed dosing
regimen for patients 1 year and older according to weight categories, the dosing for children younger than
1 year must be calculated for each patient based on their exact weight. These children should receive 3
milligrams per kilogram twice daily for five days. These smaller doses will require a different dispenser
than what is currently co-packaged with Tamiflu.
Dec 20
Reumofan Plus Relabeled and Sold as WOW. The U.S. Food and Drug Administration (FDA) is
warning the public that the potentially harmful product Reumofan Plus, marketed as a dietary supplement,
is being relabeled and sold under the name “WOW.” The product is being marketed to treat arthritis,
muscle pain, osteoporosis, bone cancer, and other conditions. FDA laboratory analysis confirmed that
“WOW” contains the same prescription drug ingredients that are in Reumofan Plus, including
dexamethasone (a corticosteroid), diclofenac sodium (a non-steroidal anti-inflammatory drug), and
methocrabamol (a muscle relaxant). These ingredients have the potential to cause serious injury.
FDA has received dozens of adverse event reports, many of them serious, from consumers who used
Reumofan Plus. The reports include liver injury, severe bleeding, corticosteroid withdrawal syndrome,
adrenal suppression, stroke, and even death.
Dec 18 Drugs to be Discontinued Ursodiol Tablets, USP, 250 mg. Teva Pharmaceuticals USA has made a
business decision to discontinue all strengths of Ursodiol Tablets.
Dec 17
International Conference on Harmonisation; Guidance on Q11 Development and Manufacture of
Drug Substances. This guidance describes approaches to developing and understanding the
manufacturing process of the drug substance, and also provides guidance on what information should be
provided in Module 3 of the Common Technical Document (CTD) sections 3.2.S.2.2 – 3.2.S.2.6. It
addresses aspects of development and manufacture that pertain to drug substance, including the presence
of steps designed to reduce impurities. In addition, this guidance provides further clarification on the
principles and concepts described in the ICH guidance, Q8 Pharmaceutical Development (ICH Q8), Q9
Quality Risk Management (ICH Q9), and Q10 Pharmaceutical Quality System (ICH Q10), as they pertain
to the development and manufacture of drug substance. Download at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM2610
78.pdf?source=govdelivery
Dec 17 Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug
Evaluation and Research-Regulated Products. This guidance provides the pharmaceutical industry
with CDER’s current thinking on the potential human health risks associated with exposure to dibutyl
phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP). In particular, the guidance recommends that you,
as part of the pharmaceutical industry, avoid the use of these two specific phthalates as excipients in
CDER-regulated drug and biologic products, including prescription and nonprescription products. Obtain
a copy from:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM2940
86.pdf
Dec 17 Draft Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Approval of
Human Drugs and Biological Products. You can download at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM3321
81.pdf?source=govdelivery
Dec 14 Prescription Drug User Fee Act (PDUFA). Establishment of PDUFA rates for 2013 was published in
August. Fees are now due. For more information, go to this Federal Register Notice:
http://www.gpo.gov/fdsys/pkg/FR-2012-08-01/pdf/2012-18711.pdf
Dec 7
Recalls: Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg. Mylan announced a
voluntary nationwide recall to the retail level of three lots of Hydrocodone Bitartrate and Acetaminophen
Tablets, USP 10 mg/500 mg (Lots 3037841, 3040859 and 3042573) due to potential for oversized tablets.
The three lots, manufactured by Qualitest Pharmaceuticals, were repackaged and distributed by Mylan in
unit dose (CD100) under the UDL Laboratories label. The lot numbers are Lots 3037841, 3040859 and
3042573.
Dec 4
Two-Week Grace Period Announced for Generic Drug Facility Identification. The FY 2013
reporting period for facility self-identification closed on December 3, 2012. Under the statute, generic
drug products manufactured in facilities that have not self-identified, or including active ingredients
manufactured in facilities that have not self-identified, are misbranded. FDA is announcing, however, that
there will be a two-week grace period, until December 18, 2012, in which facilities that have not yet
successfully completed the self-identification process may do so without penalty. To date, more than
1,700 facilities have self-identified for FY 2013. This figure is below estimates of the universe of generic
drug facilities. Similarly, an analysis of facilities identified in Abbreviated New Drug Applications and
Prior Approval Supplements submitted since October 1, 2012 suggests that not all facilities are selfidentifying. One out of eight facilities in these recent submissions has failed to self-identify, a trend that,
if uncorrected, will result in higher individual facility fee amounts. Answers to specific questions about
who must self-identify, what type of information is to be submitted and the means and format for
submission of this information is available
at http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm320942.htm.