What's New on the FDA Drugs Site
January 15, 2015
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug ShortagesGuidance for Industry: Evaluating Drug Effects on the Ability to Operate a Motor Vehicle (PDF - 190KB)
- Calcium Gluconate Injection (Updated - Currently in Shortage)
- Clindamycin Phosphate (Cleocin) Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Fluoxymesterone (Androxy) Tablets, USP (New - Currently in Shortage)
- Leuprolide Acetate Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Memantine Hydrochloride (Namenda) Tablet (Updated - Discontinuation)
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- Reserpine Tablets (Updated - Currently in Shortage)
- Sincalide (Kinevac) Lyophilized Powder for Injection (Updated - Currently in Shortage)
- List of Authorized Generic Drugs (updated)
- National Drug Code Directory
New and Generic Drug Approvals
January 14, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Isordil | isosorbide dinitrate | Tablet;Oral | Valeant Bermuda | Labeling Revision |
| Novolog | insulin aspart recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Efficacy Supplement with Clinical Data to Support |
| Novolog Flexpen | insulin aspart recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Efficacy Supplement with Clinical Data to Support |
| Novolog Flextouch | insulin aspart recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Efficacy Supplement with Clinical Data to Support |
| Novolog Innolet | insulin aspart recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Efficacy Supplement with Clinical Data to Support |
| Novolog Penfill | insulin aspart recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Efficacy Supplement with Clinical Data to Support |
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Friday, January 16, 2015
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