What's New on the FDA Drugs Site
February 7, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- MedWatch Safety Alert:Calcium gluconate 10 percent Injections by Rx Formulations: Recall - Microbial Contamination
- National Drug Code Directory
- Pediatric Exclusivity Statistics (updated)
New and Generic Drug Approvals
February 6, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aloxi | palonosetron hydrochloride | Injectable;Intravenous | Helsinn Hlthcare | Labeling Revision |
| Anadrol-50 | oxymetholone | Tablet;Oral | Meda Pharms | Manufacturing Change or Addition |
| Aripiprazole | aripiprazole | Tablet; Oral | Apotex Inc | Tentative Approval |
| Buprenex | buprenorphine hydrochloride | Injectable;Injection | Reckitt Benckiser | Manufacturing Change or Addition |
| Cisplatin | cisplatin | Injectable;Injection | Hq Spclt Pharma | Manufacturing Change or Addition |
| Imuran | azathioprine | Tablet;Oral | Prometheus Labs | Labeling Revision |
| Imuran | azathioprine sodium | Injectable;Injection | Prometheus Labs | Labeling Revision |
| Platinol | cisplatin | Injectable;Injection | Hq Spclt Pharma | Manufacturing Change or Addition |
| Platinol-Aq | cisplatin | Injectable;Injection | Hq Spclt Pharma | Manufacturing Change or Addition |
| Pramipexole Dihydrochloride | pramipexole dihydrochloride | Tablet, Extended Release;Oral | Anchen Pharms | Approval |
| Zelboraf | vemurafenib | Tablet;Oral | Hoffmann La Roche | Labeling Revision |
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