What's New on the FDA Drugs Site
April 24, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- FDA Statement in Support of the 2013 National Drug Control Strategy
- MedWatch Safety Alert: All Sterile Compounded Products by Nora Apothecary And Alternative Therapies: Recall - Lack of Sterility Assurance
- National Drug Code Directory (updated)
April 23, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (PDF - 608KB)
- Manual of Policies and Procedures (MAPP) 5015.3 Cover Form for the Technical Review of Drug Master Files (DMFs) (PDF - 47KB)
- National Drug Code Directory (updated)
New and Generic Drug Approvals
April 23, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Fluvoxamine Maleate | fluvoxamine maleate | Capsule, Extended Release; Oral | Actavis Elizabeth | Approval |
| Fluvoxamine Maleate | fluvoxamine maleate | Capsule, Extended Release; Oral | Actavis Elizabeth | Tentative Approval |
| Guanfacine Hydrochloride | guanfacine hydrochloride | Tablet, Extended Release; Oral | Teva Pharms Usa | Tentative Approval |
| Olux E | clobetasol propionate | Aerosol, Foam; Topical | Stiefel Labs Inc | Labeling Revision |
| Simponi | golimumab | Injectable; Injection | Centocor Ortho Biotech Inc | Labeling Revision |
| Sumatriptan Succinate | sumatriptan succinate | Injectable; Subcutaneous | Aurobindo Pharma Ltd | Approval |
| Telmisartan | telmisartan | Tablet; Oral | Alembic Ltd | Tentative Approval |
April 22, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Actiq | fentanyl citrate | Troche/Lozenge; Transmucosal | Cephalon | Manufacturing Change or Addition |
| Cardiogen-82 | rubidium chloride rb-82 | Injectable; Injection | Bracco | Manufacturing Change or Addition |
| Cogentin | benztropine mesylate | Injectable; Injection | Oak Pharms Akorn | Labeling Revision |
| Welchol | colesevelam hydrochloride | Tablet; Oral | Daiichi Sankyo | Manufacturing Change or Addition |
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