What's New on the FDA Drugs Site
September 4, 2012
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- National Drug Code Directory (updated)
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
August 31, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Azelastine Hydrochloride | azelastine hydrochloride | Spray, Metered; Nasal | Apotex Inc | Approval |
| Exelon | rivastigmine | Film, Extended Release; Transdermal | Novartis | Efficacy Supplement with Clinical Data to Support |
| Felbatol | felbamate | Suspension; Oral | Meda Pharms | Labeling Revision |
| Felbatol | felbamate | Tablet; Oral | Meda Pharms | Labeling Revision |
| Mirapex | pramipexole dihydrochloride | Tablet; Oral | Boehringer Ingelheim | Efficacy Supplement with Clinical Data to Support |
| Mirapex Er | pramipexole dihydrochloride | Tablet, Extended Release; Oral | Boehringer Ingelheim | Efficacy Supplement with Clinical Data to Support |
| Vinorelbine | vinorelbine | Injectable; Injection | Onco Therapies Ltd | Approval |
| Xtandi | enzalutamide | Capsule; Oral | Medivation | Approval |
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