What's New on the FDA Drugs Site

May 12, 2011

Drug Shortages: Current Drug Shortages: Calcitriol 1 mcg/mL Injection
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
FDA Issues Warning Letters to Teva Pharmaceutical Industries and Moehs Cantabra for CGMP violations
Postmarketing Drug Safety Evaluations (updated)
New and Generic Drug Approvals

May 12, 2011

Advair Diskus 100/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Advair Diskus 250/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Advair Diskus 500/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Labeling Revision
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, Sandoz, Inc., Tentative Approval
Bromfenac Sodium Ophthalmic Solution, Coastal Pharmaceuticals, Approval
Dexamethasone Elixir, Vintage Pharmaceuticals, Approval
Lexiva (fosamprenavir calcium) Tablets, ViiV Healthcare Company, Labeling Revision
Lexiva (fosamprenavir calcium) Oral Suspension, ViiV Healthcare Company, Labeling Revision
Ranitidine Hydrochloride Tablets, Perrigo R&D Company, Approval
Serevent (salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Venlafaxine Hydrochloride Extended-Release Capsules, Dr. Reddy's Laboratories, Ltd., Approval
Zerit (stavudine) Capsules, Bristol-Myers Squibb Co., Labeling Revision
Zerit (stavudine) Oral Solution, Bristol-Myers Squibb Co., Labeling Revision