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Newsletter
Vol 97 - September 2012
Featured News
Monthly News Round Up - September 2012
September 2012
Stivarga Approved Under FDA Priority Review The second new treatment in two months has been approved for the treatment of adults with metastatic colorectal cancer. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: September 27, 2012
Treatment for: Colorectal Cancer
Stivarga Drug Information | Press Release
Date of Approval: September 12, 2012
Treatment for: Multiple Sclerosis
Aubagio Drug Information | Press Release
Date of Approval: September 4, 2012
Treatment for: Chronic Myelogenous Leukemia
Bosulif Drug Information | Press Release
New Indications and Dosage Forms
Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.
New Formulation Approved: August 31, 2012
Now Approved: Exelon Patch 13.3 mg/24 hours
Exelon Drug Information | Press Release
New Indication Approved: September 21, 2012
Now Approved for: Increasing Bone Mass in Men with Osteoporosis
Prolia Drug Information | Press Release
New Indication Approved: September 28, 2012
Now Approved for: Ulcerative Colitis
Humira Drug Information | Press Release
First-Time Generic Approvals
First Time Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace.
Valsartan and Hydrochlorothiazide Tablets
USP 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg
Approved: September 21, 2012 - Mylan Pharmaceuticals Inc.
Generic for: Diovan HCT
Aprepitant Capsules
40 mg, 80 mg and 125 mg
Approved: September 24, 2012 - Sandoz Inc.
Generic for: Emend
Tolterodine Tartrate Tablets
1 mg and 2 mg
Approved: September 25, 2012 - Apotex Corp.
Generic for: Detrol
Amlodipine Besylate, Hydrochlorothiazide and Valsartan Tablets
5 mg/12.5 mg/160 mg, 10 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg
Approved: September 25, 2012 - Teva Pharmaceuticals USA Inc.
Generic for: Exforge HCT
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for July 2012. Click on a drug name to view the changes in more detail.
Key to Label Sections:
BW - Boxed Warning C - Contraindications
W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert
MG - Medication Guide PCI - Patient Counseling Information

  Sections Modified
Drug Name BW C W P AR PPI MG PCI
Avinza
(morphine sulfate) Extended-Release Capsules 
x x x x - - - -
Butrans
(buprenorphine) Transdermal System
x x x x - - - -
Dantrium
(dantrolene sodium) Oral Capsule
x - x x x - - -
Dolophine
(methadone hydrochloride) Tablets
x x x x - - - -
Duragesic
(Fentanyl Transdermal System)
x x x x - - - -
Embeda
(morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules 
x x x x - - - -
Exalgo
(hydromorphone HCl) Extended-Release Tablets 
x x x x - - - -
Kadian
(morphine sulfate) Extended-Release Capsules
x x x x - - - -
Methadone hydrochloride Oral Solution and Concentrate
x x x x - - - -
MS Contin
(Morphine Sulfate Controlled-Release) Tablets
x x x x - - - -
Nucynta ER
(tapentadol) Extended-Release Oral Tablets
x x x x - - - -
Opana ER
(oxymorphone hydrochloride) Extended-Release Tablets
x x x x - - - -
Oxycontin
(oxycodone hydrochloride controlled-release) Tablets
x x x x - - - -
Truvada
(emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets
x x x x - - - -
AzaSite
(azithromycin ophthalmic solution)
- x - - - - - -
Biaxin Filmtabs
(clarithromycin tablets) Biaxin Granules (clarithromycin for oral suspension, USP)Biaxin XL Filmtabs (clarithromycin extended release tablets)
- x x x x - - -
Diovan
(valsartan) Tablets and Diovan HCT (valsartan/hydrochlorothiazide)
- x x x x - - -
Caduet
(amlodipine/atorvastatin) Tablets
- - x x x - - -
Eraxis
(anidulafungin) Powder for Injection
- - x x - - - -
Mirapex
(pramipexole dihydrochloride)
- - x x x - - -
Natrecor
(nesiritide) for Injection 
- - x x x - - -
Prograf
(tacrolimus) Capsules and Injection
- - x x x - - -
Sanctura
(trospium chloride)
- - x x x - - -
Strattera
(atomoxetine hydrochloride) capsule
- - x x - - - -
Zinecard
(dexrazoxane) for injection
- - x x - - - -
Mircette
(desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets
- - - x - - - -
Qvar
(beclomethasone dipropionate HFA) Inhalation
- - - x x - - -
Somavert
(pegvisomant for injection)
- - - x x - - -
Sylatron
(peginterferon alfa-2b)
- - - x - - - -
Thyrogen
(thyrotropin alfa for injection)
- - - x x - - -
Trental
(pentoxifylline) Extended-Release Tablets
- - - x x - - -
Victrelis
(boceprevir) Capsules
- - - x - - - -
Faslodex
(fulvestrant) Injection
- - - - x - - -
Lumizyme
(alglucosidase alfa)
- - - - x - - -
Lupron Depot
(leuprolide acetate for depot suspension)
- - - - x - - -
Myozyme
(alglucosidase alfa)
- - - - x - - -
Ocufen
(flurbiprofen sodium ophthalmic solution, USP)
- - - - x - - -
Proleukin
(aldesleukin)
- - - - x - - -
VESIcare
(solifenacin succinate) Tablets
- - - - x - - -
Welchol
(colesevelam HCl) Tablets and Oral Suspension
- - - - x - - -
Zytiga
(abiraterone acetate) Tablets
- - - - x - - -
Note: the drug safety labeling changes listed above may not be a complete list. Please visit the link below for the entire current list and historical archive.
Other Drug News
Flu Season's Approaching So Roll Up Your Sleeve
September 27, 2012
The only thing predictable about the flu is its unpredictability, health officials said Thursday, as they urged virtually all Americans to get vaccinated for the coming season.
Prescription Drug Abuse Drops Among U.S. Young Adults
September 24, 2012
Prescription drug abuse among young adults ages 18 to 25 in the United States fell 14 percent between 2010 and 2011, according to a federal report released Monday.
Survival After General Anesthesia Vastly Improved: Study
September 20, 2012
The number of people who survive surgery when general anesthesia is used has improved dramatically over the past 50 years, Canadian researchers report.
FDA Warns Against Use of Diarrhea Drug From El Salvador
September 19, 2012
Consumers should not use a drug product called Intestinomicina - marketed as a treatment for infectious diarrhea and acute gastrointestinal infections - because it contains an ingredient that can cause serious and potentially deadly problems, the United States Food and Drug Administration warns.
More U.S. Kids Prescribed Off-Label Antipsychotics: Study
September 18, 2012
Over the past decade, off-label use of antipsychotic drugs has increased among children enrolled in Medicaid, according to a new study representing 35 percent of children in the United States.
Study Assesses Blood Thinner Use After Gastrointestinal Bleeding
September 17, 2012
New research suggests that people who stop taking the blood thinner warfarin (Coumadin) because of gastrointestinal bleeding raise their risk of blood clots and death if they stay off the drug.
Whooping Cough Vaccine Protection Fades Over Time: Study
September 12, 2012
While the whooping cough vaccine offers the best chance of protection against this potentially deadly disease, immunity provided by the vaccine appears to wane significantly every year after vaccination.
'Superpowered' Bacteria May Lurk Behind Sinus Infections
September 12, 2012
A small new study offers insight into the germ warfare that goes on inside the heads of people with chronic sinus infections.
Omega-3s May Not Help Your Heart After All, Study Says
September 11, 2012
Omega-3 fatty acids have been touted as a way to reduce the risk of a host of cardiovascular problems, but now Greek researchers report that may not be true.
When Prescription Drugs Go OTC, Ads Talk Less of Harms: Study
September 11, 2012
When prescription drugs become available over-the-counter, advertisements for the medications are far less likely to tell consumers about the potential harms and side effects, new research finds.
Common Painkillers Might Boost Odds for Second Heart Attack
September 10, 2012
People who've already suffered a heart attack may face higher odds of death or subsequent heart attack if they regularly take a common form of painkiller, Danish researchers report.
New Strep Throat Guidelines Tackle Antibiotic Resistance
September 10, 2012
Doctors need to accurately diagnose and treat strep throat in order to avoid inappropriate use of antibiotics that can lead to drug-resistant bacteria, according to updated guidelines from the Infectious Diseases Society of America.
Pediatricians' Group Urges Flu Shot for Kids Aged 6 Months and Up
September 10, 2012
The leading pediatricians' group in the United States is again urging parents to get all children aged 6 months or over immunized in preparation for the coming flu season.
Newer Rheumatoid Arthritis Drugs Don't Raise Cancer Risk: Study
September 6, 2012
A new review finds that rheumatoid arthritis medications known as biologics don't raise the risk of cancer, contrary to what some previous research has suggested.
Ginkgo Won't Prevent Alzheimer's, Study Finds
September 5, 2012
Yet another study, this one by French researchers, finds that the herbal supplement ginkgo biloba won't prevent or delay Alzheimer's disease.
FDA MedWatch Alerts
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