What's New on the FDA Drugs Site
August 9, 2012
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA approves Marqibo (vincristine sulfate liposome injection) to treat rare type of leukemia
New and Generic Drug Approvals
August 8, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Darifenacin Hydrobromide | darifenacin hydrobromide | Tablet, Extended Release; Oral | Anchen Pharms | Tentative Approval |
| Gralise | gabapentin | Tablet; Oral | Depomed Inc | Labeling Revision |
| Lithium Carbonate | lithium carbonate | Tablet, Extended Release; Oral | Mylan Pharms Inc | Approval |
| Oraqix | lidocaine; prilocaine | Gel; Periodontal | Dentsply Pharm | Labeling Revision |
| Oxaliplatin | oxaliplatin | Injectable; Iv (Infusion) | Actavis Totowa | Approval |
| Oxaliplatin | oxaliplatin | Injectable; Iv (Infusion) | Onco Therapies Ltd | Approval |
| Symbyax | fluoxetine hydrochloride; olanzapine | Capsule; Oral | Lilly | Labeling Revision |
| Topotecan Hydrochloride | topotecan hydrochloride | Injectable; Injection | Innopharma Inc | Approval |
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