What's New on the FDA Drugs Site
March 7, 2013
- 2012-2013 Influenza Season: Availability of Antivirals (updated)
- Current Drug Shortages Index (updated)
March 6, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- National Drug Code Directory (updated)
- Pediatric Exclusivity Statistics (updated)
New and Generic Drug Approvals
March 6, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amyvid | florbetapir f-18 | Solution; Intravenous | Avid Radiopharms Inc | Manufacturing Change or Addition |
| Cerebyx | fosphenytoin sodium | Injectable; Injection | Parke Davis | Labeling Revision |
| Dilantin | phenytoin sodium | Injectable; Injection | Parke Davis | Labeling Revision |
| Dilantin-125 | phenytoin | Suspension; Oral | Parke Davis | Labeling Revision |
| Dilantin-30 | phenytoin | Suspension; Oral | Parke Davis | Labeling Revision |
| Lioresal | baclofen | Injectable; Intrathecal | Medtronic | Manufacturing Change or Addition |
| Silvadene | silver sulfadiazine | Cream; Topical | King Pharms | Labeling Revision |
| Tegretol | carbamazepine | Tablet; Oral | Novartis | Labeling Revision |
| Tegretol | carbamazepine | Tablet, Chewable; Oral | Novartis | Labeling Revision |
| Tegretol | carbamazepine | Suspension; Oral | Novartis | Labeling Revision |
| Tegretol-Xr | carbamazepine | Tablet, Extended Release; Oral | Novartis | Labeling Revision |
| Zometa | zoledronic acid | Injectable; Iv (Infusion) | Novartis | Manufacturing Change or Addition |
March 5, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aggrastat | tirofiban hydrochloride | Injectable; Injection | Medicure | Manufacturing Change or Addition |
| Firmagon | degarelix acetate | Powder; Subcutaneous | Ferring | Labeling Revision |
| Lexiva | fosamprenavir calcium | Tablet; Oral | Viiv Hlthcare | Manufacturing Change or Addition |
| Oravig | miconazole | Tablet; Buccal | Vestiq Pharms | Labeling Revision |
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