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A comprehensive monthly summary of the latest drug information directly from the FDA and tailored
specifically for you Belmont University Drug Information Center Customers!
Issue 22
June 2015
Genevieve Lynn Ness, Pharm.D.
Editor
Webinars
New Drug Approvals
1. Continuing Education Webinar Series: June 25, 2015 from 12:00 pm–1:00 pm
(EST) ­ “Medication Errors: A CDER
Perspective”. Additional details regarding
this webinar will be forthcoming in a separate
email. Register Here.
2. June 23, 2015 at 1pm (EST) ­ “Introducing
the REMS@FDA Website.” The featured
speakers, Adam Kroetsch, MSPPM (Office
of Strategic Programs) and LCDR Amy
Ramanadham, PharmD, MS (Office of
Center Director) will introduce REMS@FDA,
FDA’s new REMS website. The REMS@FDA will launch June 15th. The
Viberzi (eluxadoline) for adults for the
treatment of irritable bowel syndrome with
diarrhea (IBS­D)
Kybella (deoxycholic acid) treatment for
adults with moderate­to­severe fat below the
chin, known as submental fat
Invega Trinza (paliperidone palmitate)
extended­release injectable suspension for
the treatment of schizophrenia in adult
patients who have been adequately treated
with the 1­month paliperidone palmitate
injectable product for at least four months
Rapamune (sirolimus) to treat
lymphangioleiomyomatosis (LAM), a rare,
progressive lung disease that primarily
speakers will demonstrate its new features and
show how to navigate the site. Register Here. What's New
1. From our perspective: The U.S. drug supply
chain and patient safety
2. FDA Issues Letters to Doctors Who May
Have Purchased Counterfeit or Unapproved
Prescription Drugs
3. From our perspective: Evaluating the
changing landscape of health care
antiseptics
affects women of childbearing age
Stiolto Respimat (tiotropium bromide and
olodaterol) inhalation spray for once­daily
maintenance treatment of airflow obstruction
in patients with chronic obstructive
pulmonary disease (COPD)
Tuzistra XR (codeine polistirex and
chlorpheniramine polistirex) extended
release oral suspension for the relief of
cough and symptoms associated with upper
respiratory allergies or a common cold in
adults 18 years of age and older First Generic Drug Appovals
New Indications Avelox (moxifloxacin) for treatment of
pneumonic plague (lung infection) and
septicemic plague (blood infection), as well
as the prevention of plague in adults
Treximet (sumatriptan/naproxen) for the
acute treatment of migraine with or without
aura in adolescents 12 to 17 years old
Xifaxan (rifaximin) for the treatment of
irritable bowel syndrome with diarrhea (IBS­
D) in adults New Dosing Recommendations
Alosetron hydrochloride AB rated to Lotronex
Linezolid AB rated to Zyvox
Recalls
Teva Parenteral Medicines issues voluntary
recall of select lots of Adrucil (fluorouracil
injection, USP) 5g/100ml (50mg/ml) due to
particulate matter
A listing of all recalls can be found in the
Enforcement Reports. Drug Safety Communications Breo Ellipta (fluticasone/vilanterol) ­ the daily
FDA Drug Safety Podcast: FDA cautions
treatment of asthma in patients aged 18
about dose confusion and medication errors
years and older and the addition of a 200
for antibacterial drug Zerbaxa (ceftolozane
mcg/25mcg product
and tazobactam)
Lamictal (lamotrigine) ­ the addition of
FDA warns that SGLT2 inhibitors for
pediatric safety information derived from a
diabetes may result in a serious condition of
maintenance treatment study of Bipolar I
too much acid in the blood
Disorder to delay the time to occurrence of
mood episodes (depression, mania,
Drug Safety Podcasts are also available.
hypomania, mixed episodes) in patients (≥
13 years of age) treated for acute mood
episodes with standard therapy
Dietary Supplements
Weight Loss Products Containing Sibutramine
New Medication Guides (May 2015):
Medication Guide Webpage
Slim Forte Slimming Capsule
Li Da Dai Dai Hua Slimming Capsule
Sexual Enhancer Products Containing Sildenafil
Vogelxo (testosterone)
Black Panther
Viagra 007
King of Romance Drug Shortages
Current Drug Shortages
Pain Products Containing Drug Ingredients
New: Calcium chloride injection, USP,
Chloroquine phosphate tablets, Gemifloxacin
Mesylate (Factive) Tablets, Imipenem and
Cilastatin for Injection
Resolved: Dimercaprol (Bal­in­Oil) injection,
fluorescein sodium injection, Selenium
Injection, Methylene Blue Injection,
Nalbuphine hydrochloride (Nubain) injection,
Sodium phosphate injection, Trypan blue
(Membraneblue), irrigation solutions, sterile
water for injection solutions, Radium RA­223
dichloride (Xofigo) injection
Ginseng She Lian Wan contains
dexamethasone and chlorpheniramine
Jianbu Huqian Wan contains
dexamethasone, chlorpheniramine, and
furosemide
Asihuri Plus Forte contains dexamethasone
and phenylbutazone
Saurean Fong Sep Lin contains
dexamethasone and cyproheptadine
Questions or comments?
Contact the Christy Houston
Foundation Drug Information
Center at:
[email protected]
or
615­460­8382
1900 Belmont Boulevard, Nashville, TN 37212
615.460.6748 | WWW.BELMONT. EDU
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