What's New on the FDA Drugs Site
June 14, 2012
- Drug Registration and Listing: Dun and Bradstreet Verification
- FDAAA: Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
Guidance for Industry:
- Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications (PDF - 119KB)
- Bioequivalence Recommendations for Specific Products (Updated)
New and Generic Drug Approvals
June 13, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Durezol | difluprednate | Emulsion; Ophthalmic | Alcon Pharms Ltd | Efficacy Supplement with Clinical Data to Support |
| Multaq | dronedarone hydrochloride | Tablet; Oral | Sanofi Aventis Us | Labeling Revision |
| Myobloc | botulinum toxin type b | Vial | Elan Pharm | Supplement |
| Naproxen Sodium | naproxen sodium | Capsule; Oral | Banner Pharmacaps | Labeling Revision |
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