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Newsletter
Vol 79 - March 2011
Featured News
Conflicts of Interest Cloud Heart Treatment Guidelines: Study
March 2011
More than half of the nearly 500 writers and reviewers of recent cardiology clinical practice guidelines reported a conflict of interest due to ties with drug makers and other companies, a new study finds. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: March 25, 2011
Treatment for: Melanoma - Metastatic
Yervoy Drug Information | Press Release
Date of Approval: March 14, 2011
Treatment for: Diagnostic
Gadavist Drug Information | Press Release
Date of Approval: March 10, 2011
Treatment for: Systemic Lupus Erythematosus
Benlysta Drug Information | Press Release
Date of Approval: February 28, 2011
Treatment for: Chronic Obstructive Pulmonary Disease
Daliresp 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 Dosage Form Approved: March 3, 2011
Now Approved: Banzel Oral Suspension
Banzel Drug Information | Press Release
New Formulation Approved: March 25, 2011
Now Approved: Viramune XR
Viramune Drug Information | Press Release
New Indication Approved: March 24, 2011
Now Approved for: External Genital Warts
Zyclara Drug Information | Press Release
Patient Population Altered: March 24, 2011
Now Approved for: Adults 50 Years of Age and Older
Zostavax 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.
Gabapentin Oral Solution
250 mg/5 mL
Approved: February 18, 2011 - Hi-Tech Pharmacal Co., Inc.
Generic for: Neurontin Oral Solution
Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets
15 mg/500 mg and 15 mg/850 mg
Approved: February 25, 2011 - Mylan Pharmaceuticals, Inc.
Generic for: Actoplus Met Tablets
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for February 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
Avandaryl
(rosiglitazone maleate/glimepiride) Tablets
x - x x x - - -
Proquin XR
(ciprofloxacin) Extended-Release Tablets
x - x x x - - -
Flector Patch
(diclofenac epolamine topical patch)
- x - - - - - -
Increlex
(mecasermin [rDNA origin] injection
- x x x x - - -
Toviaz
(fesoterodine fumarate) extended release tablets
- x x x - - - -
Heparin Sodium Injection
- - x - - - - -
Humatrope
(somatropin [rDNA origin]) for injection
- - x x x - - -
Kaletra
(lopinavir/ritonavir) Tablets and Oral Solution
- - x x - - - -
Multaq
(dronedarone hydrochloride) Tablets
- - x x x - - -
Promacta
(eltrombopag) Tablets
- - x x - - - -
Prilosec OTC
(omeprazole magnesium) delayed-release tablets
- - x - - - - -
Remicade
(Infliximab)
- - x x x - - -
Tekturna
(aliskiren)and Tekturna HCT(aliskiren/hydrochlorothiazide) Tablets
- - x x x - - -
Valturna
(aliskiren/valsartan) Tablets
- - x x x - - -
Zebeta
(bisoprolol fumarate) Tablets
- - x - - - - -
Adalat CC
(nifedipine)  Extended Release Tablets
- - - x x - - -
Betapace
(sotalol hydrochloride) and Betapace AF (sotalol hydrochloride) Tablets
- - - x - - - -
Cataflam
(diclofenac potassium immediate-release tablets)
- - - x x - - -
NebuPent
(pentamidine isethionate)
- - - x - - - -
Talwin Nx
(pentazocine hydrochloride and naloxone Hydrochloride) Tablets
- - - x - - - -
Tazorac
(tazarotene) Gel
- - - x x - - -
Viracept
(nelfinavir mesylate) Oral Powder and Tablets
- - - x - x - -
Voltaren
(diclofenac sodium enteric-coated tablets) and Voltaren-XR (diclofenac sodium extended-release) tablets
- - - x x - - -
Adenoscan
(adenosine) Injection
- - - - x - - -
Isentress
(raltegravir potassium) Tablets
- - - - x - - -
Micronase
(glyburide) tablets
- - - - x - - -
Pegasys
(ß (peginterferon alfa-2a)
- - - - x - - -
Simcor
(niacin extended release/simvastatin) Tablets
- - - - x - - -
Vantas
(histrelin acetate) subcutaneous implant
- - - - x - - -
Zometa
(zoledronic acid for injection)
- - - - x - - -
Brovana
(arformoterol) Inhalation Solution
- - - - - - - -
Perforomist
(formoterol fumarate) Inhalation Solution
- - - - - - - -
Plavix
(clopidogrel bisulfate) Tablets
- - - - - - - -
Symbicort
(budesonide and formoterol) Inhalation Aerosol
- - - - - - - -
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
Parkinson's Drugs Linked to Behavior Problems in Study
March 29, 2011
Parkinson's disease drugs called dopamine agonists appear to cause impulse control problems in almost one-quarter of patients, says a new study.
Nicotine Raises Blood Sugar Levels in Lab
March 27, 2011
Smoking is damaging to everyone's health, but the nicotine in cigarettes may be even more deadly for people who have diabetes.
Short Course of Hormone Therapy Boosts Prostate Cancer Survival: Study
March 24, 2011
Just six months of hormone therapy, along with radiation, cuts the risk of dying from locally advanced prostate cancer in half when compared to radiation alone, researchers report.
Leukemia Patients Taking Gleevec Achieve 'Normal' Death Rate
March 22, 2011
The death rate of patients with chronic myeloid leukemia who took Gleevec and were in remission two years after treatment was similar to the death rate in the general population, a new study shows.
Study: Reluctance to Speak Up Encourages Medical Errors
March 22, 2011
Nurses often don't speak up about incompetent colleagues or when they see fellow health-care workers making mistakes that could harm patients, new research finds.
Tamoxifen May Offer Long-Term Heart, Cancer Protection
March 22, 2011
Taking the breast cancer drug tamoxifen for the recommended five years protects women from breast cancer recurrence better than a two-year course of the drug and it also shields some women from cardiovascular disease, new research finds.
Anti-Drug Message May Reach Young Girls, But Not Older Ones
March 18, 2011
Anti-drug ads appear to be an effective way of delaying and reducing marijuana use by eighth-grade girls in the United States, a new study has found.
Parents Can Help Prevent Problem Drinking in College Kids
March 16, 2011
College students are less likely to have drinking problems or engage in risky behavior if their parents monitor their social lives, researchers have found.
Herbal Derivative Wins Praise as Malaria Treatment
March 16, 2011
Artesunate should replace quinine as the drug of choice for treating malaria, according to an updated review of clinical trial results.
Heavy Smoking Declines in U.S.
March 15, 2011
The number of people who smoke a pack or more a day has dropped significantly in the United States, and perhaps nowhere more than in California, a new study finds.
Seniors Not Getting Important Preventive Health Services
March 15, 2011
Many Americans aged 65 and older are not receiving potentially lifesaving preventive health services, says a new report by several United States Department of Health and Human Services agencies.
Metformin Still Best First-Line Type 2 Diabetes Drug
March 14, 2011
Although there are numerous options in oral medications for type 2 diabetes, an older drug - metformin - may be the best first-line option, according to a new analysis of research on diabetes medications.
Combating Myths About Seasonal Allergies
March 13, 2011
With spring allergy season looming, people need to know the facts about controlling their allergies, says the American College of Allergy, Asthma and Immunology.
Spider Research May Lead to New Therapies for Humans
March 9, 2011
A newly identified toxin in spider venom may help lead to new ways to treat pain and disease in humans, scientists report.
Genes May Affect Severity of Drug Addiction
March 8, 2011
Treatment for drug addiction is affected by a person's genetic makeup and the duration of substance abuse, United States scientists report.
Diabetes Often Not Diagnosed or Treated Properly
March 4, 2011
Poor diagnosis and ineffective treatment of diabetes may put millions of people worldwide at risk for early death, a new study finds.
Seniors Concerned About Side Effects of Heart Drugs
March 1, 2011
Older adults carefully weigh the benefits and risks of cardiovascular disease prevention drugs before they decide whether to take them, finds a new study.
Blood Pressure Drugs May Help Heart Patients Without Hypertension
March 1, 2011
In people with heart disease, the use of blood pressure-lowering medications can be beneficial, even in those who don't have high blood pressure, new research suggests.
FDA MedWatch Alerts
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