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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.
New Indications and Dosage Forms
Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.
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
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
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.
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.
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. |
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