What's New on the FDA Drugs Site
November 4, 2013
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- MedWatch Safety Alert: Perrigo Acetaminophen Infant Suspension Liquid: Recall - Potential Defect with Co-packaged Oral Syringe
- National Drug Code Directory
- Spanish FDA Drug Safety Communication: Iclusig: FDA pide al fabricante del medicamento Iclusig (ponatinib) para la leucemia que suspenda mercadeo y venta
New and Generic Drug Approvals
November 1, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Belviq | lorcaserin hydrochloride | Tablet;Oral | Eisai Inc | Manufacturing Change or Addition |
| Embeda | morphine sulfate; naltrexone hydrochloride | Capsule, Extended Release;Oral | Alpharma King | Manufacturing Change or Addition |
| Evoxac | cevimeline hydrochloride | Capsule;Oral | Daiichi Sankyo | Manufacturing Change or Addition |
| Exjade | deferasirox | Tablet, For Suspension;Oral | Novartis | Manufacturing Change or Addition |
| Gazyva | obinutuzumab | Injectable;Injection | Genentech | Approval |
| Latisse | bimatoprost | Solution/Drops;Topical | Allergan | Manufacturing Change or Addition |
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