What's New on the FDA Drugs Site
July 5, 2012
- Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
- Drug Firm Annual Registration Status Download File
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Download File (updated)
- FDA prompts companies to remove certain unapproved oxycodone products from market
- FDA Safety Podcast: New information regarding QT prolongation with ondansertron (Zofran)
- Pediatric Statistics: Pediatric Exclusivity Granted (updated)
- Guidance for Industry: Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Labeling for Products That Contain Acetaminophen
- Drug Shortages: Current Drug Shortages: Amphetamine Mixed Salts Immediate-Release Tablets (updated)
- Drug Shortages: Current Drug Shortages: Etomidate Injection (updated)
- Drug Shortages: Current Drug Shortages: Isoniazid Tablets (updated)
- Drug Shortages: Current Drug Shortages: Methazolamide Tablets (new)
New and Generic Drug Approvals
July 3, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Estraderm | estradiol | Film, Extended Release; Transdermal | Novartis | Labeling Revision |
| Pregabalin | pregabalin | Capsule; Oral | Lupin Ltd | Approval |
| Pregabalin | pregabalin | Capsule; Oral | Teva Pharms | Approval |
| Pregabalin | pregabalin | Capsule; Oral | Watson Labs Inc | Approval |
| Pregabalin | pregabalin | Capsule; Oral | Teva Pharms | Approval |
| Somavert | pegvisomant | Injectable; Subcutaneous | Pharmacia and Upjohn | Labeling Revision |
| Trental | pentoxifylline | Tablet, Extended Release; Oral | Sanofi Aventis Us | Labeling Revision |
| Zinecard | dexrazoxane hydrochloride | Injectable; Injection | Pharmacia and Upjohn | Labeling Revision |
| Zytiga | abiraterone acetate | Tablet; Oral | Janssen Biotech | Labeling Revision |
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