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Newsletter
Vol 81 - May 2011
Featured News
Lists of Prescription Meds' Side Effects Keep Growing: Study
May 2011
Lists of the side effects for prescription medications on drug labels, packaging and advertisements have mushroomed up to an average of 70 per medication, a new study reports. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: May 27, 2011
Treatment for: Clostridial Infection
Dificid Drug Information | Press Release
Date of Approval: May 23, 2011
Treatment for: Chronic Hepatitis C
Incivek Drug Information | Press Release
Date of Approval: May 20, 2011
Treatment for: HIV Infection
Edurant Drug Information | Press Release
Date of Approval: May 13, 2011
Treatment for: Chronic Hepatitis C
Victrelis Drug Information | Press Release
Date of Approval: May 2, 2011
Treatment for: Diabetes Mellitus Type II
Tradjenta 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 Indication Approved: May 6, 2011
Now Approved for: Pancreatic Neuroendocrine Tumors
Afinitor Drug Information | Press Release
New Indication Approved: May 20, 2011
Now Approved for: Pancreatic Neuroendocrine Tumors
Sutent 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.
Exemestane Tablets
25 mg
Approved: April 1, 2011 - Roxane Laboratories, Inc.
Generic for: Aromasin Tablets
Paroxetine Hydrochloride Extended-Release Tablets
37.5 mg (base)
Approved: April 14, 2011 - Mylan Pharmaceuticals, Inc.
Generic for: Paxil CR Tablets
Cyclobenzaprine Hydrochloride Extended-Release Capsules
15 mg and 30 mg
Approved: April 18, 2011 - Mylan Pharmaceuticals, Inc.
Generic for: Amrix Extended-Release Capsules
Desloratadine and Pseudoephedrine Sulfate Extended-Release Tablets
5 mg/240 mg (24-Hour Formulation)
Approved: April 26, 2011 - Dr. Reddy's Laboratories Limited
Generic for: Clarinex-D 24-Hour Extended-Release Tablets
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for April 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
Aplenzin
(bupropion hydrobromide) Extended-Release Tablets
x - x x x - - -
Fosrenol
(lanthanum carbonate) Chewable Tablets
- x x x x - - -
Advil PM Liqui-Gels
(ibuprofen 200 mg/diphenhydramine hydrochloride 25 mg) capsules
- - x - - - - -
Aleve
(naproxen sodium) tablets
- - x - - - - -
Combivent
(ipratropium bromide and albuterol sulfate) Aerosol
- - x x x - - -
Cyanokit
(hydroxocobalamin for Injection)
- - x x - - - -
Demerol
(meperidine hydrochloride)
- - x x x - - -
Eligard
(leuprolide acetate) injectable suspension
- - x x - - - -
Fuzeon
(enfuvirtide) for Injection
- - x x - - - -
Gleevec
(imatinib mesylate) Tablets
- - x x x - - -
Invega
(paliperidone) extended-release tablets
- - x x - - - -
Janumet
(sitagliptin/metformin hydrochloride) Tablets
- - x x x - - -
Januvia
(sitagliptin) Tablets
- - x x x - - -
Lysteda
(tranexamic acid) Tablets
- - x x - - - -
Omnitrope
(somatropin [rDNA origin] injection)
- - x x - - - -
Pregnyl
(chorionic gonadotropin for Injection, USP)
- - x - - - - -
Zemplar
(Paricalcitol) Injection
- - x x x - - -
Aclovate
(alclometasone dipropionate) Cream
- - - x - - - -
Aptivus
(tipranavir) Capsules and Oral Solution
- - - x - - - -
Diflucan
(fluconazole) Tablets and I.V.
- - - x - - - -
Exjade
(deferasirox) Tablets for Oral Suspension
- - - x - - - -
Kytril
(granisetron hydrochloride) Intravenous Injection
- - - x - - - -
Pexeva
(paroxetine mesylate) Tablets
- - - x - - - -
Qualaquin
(quinine sulfate USP) Capsules
- - - x - - - -
Voltaren Ophthalmic
(diclofenac sodium ophthalmic solution)
- - - x x - - -
Aredia
(pamidronate disodium) for Injection
- - - - x x - -
Arimidex
(anastrozole) Tablets
- - - - x - - -
Cymbalta
(duloxetine hydrochloride)
- - - - x x - -
Isentress
(raltegravir potassium) Tablets
- - - - x - - -
Propecia
(finastride) Tablet
- - - - x - - -
Prozac Weekly
(fluoxetine hydrochloride)
- - - - x - - -
Relpax
(eletriptan) Tablets
- - - - x - - -
Singulair
(montelukast sodium) Tablets, Chewable Tablets and Oral Granules
- - - - x x - -
Symbyax
(olanzapine and fluoxetine HCL) Capsules
- - - - x - - -
MoviPrep
(PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride,Sodium Ascorbate, and Ascorbic Acid for Oral Solution)
- - - - - - - -
Pristiq
(desvenlafaxine) Extended-Release Tablets
- - - - - - - -
Rythmol SR Extended-Release Capsules
- - - - - 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
Daily Four-Drug Combo Pill Halves Heart Disease Risk: Study
May 25, 2011
A cheap, once-daily, four-drugs-in-one medication, dubbed a "polypill," appears to cut users' odds for heart disease and stroke by 50 percent, a new international study finds.
With Calcium, More May Not Be Better
May 24, 2011
Getting enough calcium for bone health is essential, but getting more than that doesn't appear to confer any additional benefit, Swedish researchers have found.
Too Many Kids Getting Antibiotics for Asthma
May 24, 2011
Although guidelines don't recommend antibiotics for asthma, almost 1 million children with the respiratory condition are prescribed the medications each year in the United States, a new study finds.
Certain COPD Meds Linked to Urinary Troubles in Men
May 23, 2011
New research suggests that a certain class of drugs used to treat chronic obstructive pulmonary disease (COPD) boosts the risk that male patients will be unable to urinate.
Side Effects May Sway Drug Choices for Tough-to-Manage Diabetes
May 19, 2011
When someone with type 2 diabetes needs a third medication to control blood sugar levels, the choice may come down to which drug has the least undesirable side effects, because the available medications all lower blood sugar in a similar manner.
FDA to Pull Diabetes Drug Avandia From Pharmacy Shelves
May 19, 2011
The U.S. Food and Drug Administration has announced that the controversial diabetes drug Avandia will no longer be sold at retail pharmacies beginning this November, due to the cardiovascular risks it poses to patients.
FDA Advisers Urge Infant Doses for Kids' OTC Fever Relievers
May 18, 2011
U.S. health advisers have recommended that dosing instructions should be added to the labels of medicines containing the widely used pain reliever and fever reducer acetaminophen to better protect children under the age of 2.
Newer Epilepsy Meds Less Likely to Cause Birth Defects: Study
May 17, 2011
Newer epilepsy medications don't increase the risk of major birth defects in women taking these drugs during the first trimester of pregnancy, according to new research.
ADHD Drug Shortage Has Patients, Parents Scrambling
May 11, 2011
Due to an ongoing shortage, some American adults with attention-deficit hyperactivity disorder (ADHD), or the parents of children with ADHD, are having to call multiple pharmacies before finding one that carries the prescription they need to manage the condition.
Asthma Pills Work as Well as Inhaled Steroids: Study
May 4, 2011
In a study that compared asthma pills against commonly prescribed inhaled steroids, British researchers found that the oral medications were as effective as the inhaled drugs.
Many Consumers Don't Know What's in Over-the-Counter Painkillers: Study
May 3, 2011
Few Americans bother to read the labels on over-the-counter pain relievers, nor do they pay much attention to the drugs' ingredients, a new study says.
Study Questions Giving Babies Botanical Supplements, Teas
May 2, 2011
The use of botanical supplements and teas for infants is a surprisingly common practice, new research finds, but experts warn that such products might not be safe for babies.
FDA MedWatch Alerts
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