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
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