What is new in FDA

May 19, 2011

Chantix: Quarterwatch Article
Drug Shortages: Current Drug Shortages: Acetylcysteine inhalation solution (updated)
Drug Shortages: Current Drug Shortages: Ammonium molybdate injection
Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
Drug Shortages: Current Drug Shortages: Pentosan Polysulfate sodium 100mg capsules
Drug Shortages: Current Drug Shortages: Sodium Chloride 14.6% (updated)
New and Generic Drug Approvals

May 19, 2011

Faslodex (fulvestrant) Injection, AstraZeneca Pharmaceuticals LP, Efficacy Supplement
Foradil (formoterol fumarate) Inhalation Powder, Novartis Pharmaceuticals Corp., Labeling Revision
Gemcitabine Injection, APP Pharmaceuticals, LLC, Approval
Genotropin (somatropin [rDNA origin]) Injection, Pfizer, Inc., Labeling Revision
Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline Consumer Healthcare, L.P., Labeling Revision
Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline Consumer Healthcare, L.P., Labeling Revision
Potassium Chloride Extended-Release Capsules, Paddock Laboratories, Inc., Approval
Pravachol (pravastatin sodium) Tablets, Bristol-Myers Squibb Co., Labeling Revision
Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
Vagifem (estradiol) Vaginal Tablets, Novo Nordisk Pharmaceuticals, Inc., Labeling Revision
Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision