What's New on the FDA Drugs Site
January 29, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- National Drug Code Directory
New and Generic Drug Approvals
January 28, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Betaseron | interferon beta-1b | Vial; Subcutaneous | Bayer Healthcare Pharms | Labeling Revision |
| Copaxone | glatiramer acetate | For Solution;Subcutaneous | Teva Pharms Usa | Efficacy Supplement with Clinical Data to Support |
| Copaxone | glatiramer acetate | Injectable;Subcutaneous | Teva Pharms Usa | Efficacy Supplement with Clinical Data to Support |
| Desvenlafaxine | desvenlafaxine fumarate | Tablet, Extended Release;Oral | Sun Pharma Global | Approval |
| Restasis | cyclosporine | Emulsion;Ophthalmic | Allergan | Manufacturing Change or Addition |
| Retin-A Micro | tretinoin | Gel;Topical | Valeant Intl | Manufacturing Change or Addition |
| Singulair | montelukast sodium | Tablet;Oral | Merck | Manufacturing Change or Addition |
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