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Newsletter
Vol 88 - December 2011
Featured News
Monthly Roundup - December 2011
December 2011
Durasal and Durezol: Potential for Patient Injury Due to Name Mix-Up The Food and Drug Administration (FDA) is alerting pharmacists and other health care providers of the potential for ocular injury if the unapproved prescription drug Durasal (salicylic acid) is confused with the FDA-approved medication Durezol (difluprednate ophthalmic emulsion). Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: December 7, 2011
Treatment for: Overactive Bladder
Anturol 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: December 9, 2011
Now Approved: Opana ER Crush-Resistant Formulation
Opana Drug Information | Press Release
Patient Population Altered: December 21, 2011
Now Approved for: HIV Infection in Children and Adolescents
Isentress 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.
Tiagabine Hydrochloride Tablets
2 mg and 4 mg
Approved: November 4, 2011 - Sun Pharmaceutical Industries, Ltd.
Generic for: Gabitril
Levocetirizine Dihydrochloride Oral Solution
2.5 mg/5 mL
Approved: November 7, 2011 - Synthon Pharmaceuticals, Inc.
Generic for: Xyzal Oral Solution
Morphine Sulfate Extended-Release Capsules
USP 20 mg, 30 mg, 50 mg, 60 mg, 80 mg and 100 mg
Approved: November 10, 2011 - Watson Laboratories, Inc.
Generic for: Kadian
Eprosartan Mesylate Tablets
400 mg (base) and 600 mg (base)
Approved: November 16, 2011 - Mylan Pharmaceuticals, Inc.
Generic for: Teveten
Imipenem and Cilastatin for Injection
USP, (I.V.) 250 mg/250 mg (base) and 500 mg/500 mg (base)
Approved: November 16, 2011 - Hospira Inc.
Generic for: Primaxin I.V.
Lamivudine Tablets
150 mg and 300 mg
Approved: November 17, 2011 - Aurobindo Pharma USA, Inc.
Generic for: Epivir Tablets
Sodium Phenylbutyrate Tablets
500 mg
Approved: November 18, 2011 - Amplogen Pharmaceuticals, LLC
Generic for: Buphenyl Tablets
Atorvastatin Calcium Tablets
10 mg (base), 20 mg (base), 40 mg (base) and 80 mg (base)
Approved: November 30, 2011 - Ranbaxy Laboratories Limited
Generic for: Lipitor
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for November 2011. 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
Cerebyx
(fosphenytoin sodium) Injection
x x x x - - - -
Dilantin
(phenytoin sodium, USP) Injection
x x x x x - - -
Dilantin
(phenytoin) Oral Suspension
- x x x x - - -
Kombiglyze XR
(saxagliptin/metformin hydrochloride extended-release) Tablets
- x x x x - - -
Mytelase
(ambenonium chloride) Tablets
- x - x x - - -
Onglyza
(saxagliptin) Tablets
- x x x x - - -
Amturnide
(aliskiren/amlodipine/hydrochlorothiazide) Tablets
- - x x - - - -
Isentress
(raltegravir potassium) Tablets
- - x x x - - -
Lioresal Intrathecal
(baclofen injection)
- - x x - - - -
Methotrexate Sodium for Injection
- - x - - - - -
Tekamlo
(aliskiren/amlodipine) Tablets
- - x x - - - -
Toviaz
(fesoterodine fumarate) Extended Release Tablets
- - x x - - - -
Tribenzor
(olmesartan medoxomil, amlodipine, hydrochlorothiazide) Tablets
- - x x - - - -
Twynsta
(telmisartan/amlodipine)
- - x x - - - -
VFEND
(voriconazole) Tablets, I.V. for Infusion and Oral Suspension
- - x x x - - -
Vimovo
(naproxen/esomeprazole magnesium) Tablets
- - x x x - - -
Ziagen
(abacavir sulfate) Tablets and Oral Solution
- - x x - - - -
Zyflo CR
(zileuton) Extended Release Tablets
- - x x - - - -
Agrylin
(anagrelide hydrochloride) Capsule
- - - x - - - -
Amoxil
(amoxicillin) Chewable Tablets, Tablets and Oral Suspension
- - - x - - - -
Cordarone
(amiodarone HCl) Tablets
- - - x - - - -
Cozaar
(losartan) Tablets
- - - x - x - -
Hyzaar
(losartan/hydrochlorothiazide) Tablets
- - - x - x - -
Prinivil
(lisinopril) Tablets
- - - x - x - -
Prinzide
(lisinopril/hydrochlorothiazide) Tablets
- - - x - x - -
Protopic
(tacrolimus) Ointment
- - - x x - - -
Treximet
(sumatriptan/naproxen) Tablets
- - - x - - - -
Verelan PM
(verapamil hydrochloride) Extended-Release CapsulesVerelan (verapamil hydrochloride) Sustained-Release Capsules
- - - x - - - -
Lamisil
(terbinafine hydrochloride) Tablets and Oral Granules
- - - - x - - -
Tasigna
(nilotinib) Capsules
- - - - x - - -
Velcade
(bortezomib) for Injection
- - - - x - - -
Viramune
(nevirapine) Tablets, Oral Suspension and Virammune XR Extended-Release Tablets
- - - - x - - -
AndroGel
(testosterone gel)
- - - - - - - -
Lamictal
(lamotrigine) Tablets, Chewable Dispersible Tablets, Orally Disintegrating Tablets, and Lamictal XR (lamotrigine) Extended-Release Tablets
- - - - - - - -
Testim
(testosterone gel)
- - - - - - - -
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
Health Care Reform Battle Tops Health News for 2011
December 29, 2011
While no one story dominated health news in 2011, the ongoing debate over the legality of the new health care reform law was perhaps the most polarizing, with the case now set to go to the United States Supreme Court early in 2012.
Cases of Tamiflu-Resistant Flu Concern Experts
December 28, 2011
World Health Organization researchers are reporting an apparent spike in Australia in the number of seasonal influenza cases resistant to Tamiflu, the most commonly used antiviral drug.
FDA Alerts Pharmacists and Health Care Professionals to Potential for Injury when Dispensing the Similar-Sounding Drugs Durezol and Durasal
December 28, 2011
FDA is alerting pharmacists and other health care professionals of potential injury due to confusion between the FDA-approved eye medicine Durezol (difluprednate ophthalmic emulsion) and the unapproved prescription topical wart remover Durasal (salicylic acid).
How to Make Your Quit-Smoking Resolution Stick
December 26, 2011
Quitting smoking is one of the most common New Year's resolutions, but it's easier said than done, with six of 10 smokers requiring multiple attempts before successfully kicking the habit, according to the American Lung Association.
Limit Cold Medications During Pregnancy, Experts Advise
December 21, 2011
It's prudent to limit the use of over-the-counter cold and flu medications during pregnancy, experts say.
Treating High Blood Pressure May Add Years to Life
December 20, 2011
People suffering from high blood pressure, or hypertension, who keep their blood pressure levels under control may add years to their life, a new study suggests.
Drug Overdoses Kill More Americans Than Car Accidents: CDC
December 20, 2011
More Americans now die from drug overdoses than in car accidents, according to a new government report.
Poor Lifestyles Harming U.S. Heart Health: Report
December 15, 2011
Americans' heart health is in a woeful state, says this year's report card from the American Heart Association.
Many Toddlers Wind Up in ER After Accidental Overdose
December 13, 2011
Each year in the United States, one of every 150 two-year-olds visits an emergency room for treatment of an accidental medication overdose, a new government report shows.
Side Effects Cause Many Older Women to Drop Breast Cancer Drugs
December 12, 2011
Severe side effects may be key to why so many older breast cancer patients stop taking drugs that can help prevent a tumor's return, a new study finds.
ADHD Drugs Don't Raise Risk of Heart Problems: Study
December 12, 2011
Young and middle-aged adults taking drugs for attention deficit-hyperactivity disorder (ADHD) do not seem to face an increased risk for cardiovascular disease, a new study finds.
CDC Issues New TB Treatment Guidelines
December 8, 2011
New guidelines on treating so-called "latent" tuberculosis infection in the United States should significantly shorten and simplify the course of the therapy from about 9 months to 3 months, according to the Centers for Disease Control and Prevention.
Expert Panel Pinpoints Environmental Culprits in Breast Cancer
December 7, 2011
Women can lower their risk of developing breast cancer by avoiding unnecessary medical radiation, forgoing menopausal hormone therapy and limiting alcohol use, but they don't need to worry about using hair dyes or cellphones, a broad new national report says.
FDA Targets Homeopathic Weight Loss Products
December 6, 2011
U.S. officials are taking action to remove controversial, unapproved and illegally labeled HCG weight loss products from the market.
Targeted Drugs, Lung CT Screening Top Cancer Advances in 2011
December 6, 2011
As the war against cancer continues, a group representing American oncologists has picked its "Top Five" list of advances in cancer care for 2011.
FDA MedWatch Alerts
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