What's New on the FDA Drugs Site

June 10, 2011

Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
Drug Shortages: Current Drug Shortages: Amphetamine Mixed Salts, ER Capsules (updated)
Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
Drug Shortages: Current Drug Shortages: Cytarabine Injection (updated)
Drug Shortages: Current Drug Shortages: Dexamethasone Injection (updated)
Drug Shortages: Current Drug Shortages: Etoposide solution for injection (updated)
Drug Shortages: Current Drug Shortages: Leucovorin Calcium Lyophilized Powder for Injection (updated)
Drug Shortages: Current Drug Shortages: Neostigmine methylsulfate injection (updated)
Drug Shortages: Current Drug Shortages: Sodium Chloride 23.4%(updated)
FDA approves redesigned labels for some Merck drugs
FDA Drug Safety Podcast for Healthcare Professionals: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals

June 10, 2011

Avodart (dutasteride) Capsules, GlaxoSmithKline, Efficacy Supplement with Clinical Data to Support
Avodart (dutasteride) Capsules, GlaxoSmithKline, Labeling Revision
Docetaxel Injection, Accord Healthcare, Inc., Approval
Estradiol and Norethindrone Acetate Tablets, Breckenridge Pharmaceutical, Inc., Chemistry New Strength
Intuniv (guanfacine hydrochloride) Extended-Release Tablets, Shire Development, Inc., Labeling Revision
Jalyn (dutasteride and tamsulosin hydrochloride) Capsules, GlaxoSmithKline, Labeling
Revision
Mifeprex (mifepristone) Tablets, Danco Laboratories, LLC, Labeling Revision
Mupirocin Ointment, Glenmark Generics, Ltd., Approval
PerioChip (chlorhexidine gluconate) Dental Tablets, Dexcel Pharma Technologies, Ltd., Labeling Revision
Propecia (finasteride) Tablets, Merck Sharp & Dohme Corp., Labeling Revision
Proscar (finasteride) Tablets, Merck Sharp & Dohme Corp., Labeling Revision
Ramipril Capsules, Aurobindo Pharma, Ltd., Approval
Simcor (niacin and simvastatin) Extended-Release Tablets, Abbott Laboratories, Labeling Revision
Vytorin (ezetimibe and simvastatin) Tablets, MSP Singapore Co., LLC, Labeling Revision
Zocor (simvastatin) Tablets, Merck Sharp & Dohme Corp., Labeling Revision
Zutripro (hydrocodone, chlorpheniramine and pseudoephedrine) Oral Solution, Cypress Pharmaceuticals, Approval