What's New on the FDA Drugs Site
May 30, 2014
- Agenda: Advancing the Development of Pediatric Therapeutics (ADEPT): Pediatric Bone Health (PDF - 55KB)
- Current Drug Shortages Index (updated)
- Resolved Drug Shortages: Methazolamide (Glauctabs, Neptazane) Tablets
- Resolved Drug Shortages: Telavancin (Vibativ) Injection
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
New and Generic Drug Approvals
May 29, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amoxil | amoxicillin | For Suspension;Oral | Dr Reddys Labs Inc | Manufacturing Change or Addition |
| Azilect | rasagiline mesylate | Tablet;Oral | Teva | Efficacy Supplement with Clinical Data to Support |
| Azilect | rasagiline mesylate | Tablet;Oral | Teva | Labeling Revision |
| Differin | adapalene | Lotion;Topical | Galderma Labs Lp | Manufacturing Change or Addition |
| Entereg | alvimopan | Capsule;Oral | Cubist Pharms | Manufacturing Change or Addition |
| Femring | estradiol acetate | Insert, Extended Release;Vaginal | Warner Ireland | Labeling Revision |
| Lovenox | enoxaparin sodium | Injectable;Intravenous, Subcutaneous | Sanofi Aventis Us | Manufacturing Change or Addition |
| Lovenox (Preservative Free) | enoxaparin sodium | Injectable;Subcutaneous | Sanofi Aventis Us | Manufacturing Change or Addition |
| Lunesta | eszopiclone | Tablet;Oral | Sunovion Pharms Inc | Manufacturing Change or Addition |
| Maxalt | rizatriptan benzoate | Tablet;Oral | Merck | Manufacturing Change or Addition |
| Maxalt-Mlt | rizatriptan benzoate | Tablet, Orally Disintegrating;Oral | Merck | Manufacturing Change or Addition |
| Minocin | minocycline hydrochloride | Capsule;Oral | Precision Dermat | Manufacturing Change or Addition |
| Mirena | levonorgestrel | Intrauterine Device;Intrauterine | Bayer Hlthcare | Manufacturing Change or Addition |
| Suprax | cefixime | For Suspension;Oral | Lupin Ltd | Labeling Revision |
| Zoledronic Acid | zoledronic acid | Injectable;Injection | Cipla Ltd | Tentative Approval |
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