What's New on the FDA Drugs Site
February 6, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Public Meeting on Pulmonary Arterial Hypertension Patient-Focused Drug Development, May 13, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information
- Spanish FDA Drug Safety Communication: Productos con testosterona: La FDA evalúa riesgo de derrame, ataque cardiaco y muerte por usar productos con testosterona aprobados por la FDA
New and Generic Drug Approvals
February 5, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Disulfiram | disulfiram | Tablet; Oral | Roxane | Approval |
| Doxercalciferol | doxercalciferol | Injectable; Injection | Sandoz Inc | Approval |
| Fludeoxyglucose F-18 | fludeoxyglucose f-18 | Injectable;Injection | Washington Univ Sch Medicine | Approval |
| Fludeoxyglucose F-18 | fludeoxyglucose f-18 | Injectable;Injection | Essential Isotopes Llc | Approval |
| Ilevro | nepafenac | Suspension/Drops;Ophthalmic | Alcon Res Ltd | Manufacturing Change or Addition |
| Levonorgestrel; Ethinyl Estradiol | levonorgestrel; ethinyl estradiol | Tablet; Oral | Haupt Pharma | Approval |
| Morphine Sulfate | morphine sulfate | Solution; Oral | Caraco | Approval |
| Phentermine Hydrochloride | phentermine hydrochloride | Capsule; Oral | Invagen Pharms | Approval |
| Phentermine Hydrochloride | phentermine hydrochloride | Tablet; Oral | Invagen Pharms | Approval |
| Pylera | bismuth subcitrate potassium; metronidazole; tetracycline | Capsule;Oral | Aptalis Pharma Us | Manufacturing Change or Addition |
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