What's New on the FDA Drugs Site
June 15, 2012
- CDER Forum for International Drug Regulatory Authorities (updated)
- Drug Firm Annual Registration Status Download File
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Digoxin Injection (updated)
- Drug Shortages: Current Drug Shortages: Hydromorphone Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Ketorolac Injection (updated)
- Drug Shortages: Resolved Drug Shortages: XENON Xe 133 Gas
- Electronic Common Technical Document (eCTD) Module 1: Public Meeting on Module 1 Updates. Meeting and registration information
- Medication Guides (updated)
New and Generic Drug Approvals
June 14, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acular | ketorolac tromethamine | Solution/Drops; Ophthalmic | Allergan | Labeling Revision |
| Adapalene | adapalene | Gel; Topical | Tolmar | Approval |
| Atripla | efavirenz; emtricitabine; tenofovir disoproxil fumarate | Tablet; Oral | Gilead | Labeling Revision |
| Cubicin | daptomycin | Injectable; Iv (Infusion) | Cubist | Labeling Revision |
| Increlex | mecasermin recombinant | Injectable; Subcutaneous | Ipsen Inc | Labeling Revision |
| M.V.I.-12 | ascorbic acid; biotin; cyanocobalamin; dexpanthenol; ergocalciferol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a; vitamin e | Injectable; Injection | Hospira | Labeling Revision |
| M.V.I.-12 | ascorbic acid; biotin; cyanocobalamin; dexpanthenol; ergocalciferol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin; thiamine hydrochloride; vitamin a; vitamin e | Injectable; Injection | Hospira | Labeling Revision |
| M.V.I.-12 (Without Vitamin K) | ascorbic acid; biotin; cyanocobalamin; dexpanthenol; ergocalciferol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a; vitamin e | Injectable; Injection | Hospira | Labeling Revision |
| Stelara | ustekinumab | Injectable; Injection | Centocor Ortho Biotech Inc | Supplement |
| Strattera | atomoxetine hydrochloride | Capsule; Oral | Lilly | Labeling Revision |
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