What's New on the FDA Drugs Site
March 28, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Instructions for Requesting Individual Case Reports
- National Drug Code Directory (updated)
- Presentation: How FDA Promotes Partnerships to Accelerate Medical Product Development (PDF - 1.4MB)
New and Generic Drug Approvals
March 27, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aranesp | darbepoetin alfa | Vial; Intravenous | Amgen | Labeling Revision |
| Aranesp | darbepoetin alfa | Vial; Subcutaneous | Amgen | Labeling Revision |
| Dimethyl Fumarate | dimethyl fumarate | Capsule, Delayed Release; Oral | Biogen Idec | Approval |
| Emend | aprepitant | Capsule; Oral | Merck | Labeling Revision |
| Emend | fosaprepitant dimeglumine | Powder; Intravenous | Merck and Co Inc | Labeling Revision |
| Epogen/Procrit | epoetin alfa | Vial; Multidose | Amgen | Labeling Revision |
| Epogen/Procrit | epoetin alfa | Vial; Single-Use | Amgen | Labeling Revision |
| Gralise | gabapentin | Tablet; Oral | Depomed Inc | Manufacturing Change or Addition |
| Kadian | morphine sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth | Labeling Revision |
| Lantus | insulin glargine recombinant | Injectable; Injection | Sanofi Aventis Us | Manufacturing Change or Addition |
| Multaq | dronedarone hydrochloride | Tablet; Oral | Sanofi Aventis Us | Labeling Revision |
| Noroxin | norfloxacin | Tablet; Oral | Merck | Labeling Revision |
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