What's New on the FDA Drugs Site
February 15, 2013
- Current Drug Shortages Index (updated)
New and Generic Drug Approvals
February 14, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aripiprazole | aripiprazole | Tablet; Oral | Sun Pharma Global | Tentative Approval |
| Cellcept | mycophenolate mofetil | Capsule; Oral | Roche Palo | Manufacturing Change or Addition |
| Cellcept | mycophenolate mofetil | Tablet; Oral | Roche Palo | Manufacturing Change or Addition |
| Cellcept | mycophenolate mofetil hydrochloride | Injectable; Injection | Roche Palo | Manufacturing Change or Addition |
| Cellcept | mycophenolate mofetil | Suspension; Oral | Roche Palo | Manufacturing Change or Addition |
| Emcyt | estramustine phosphate sodium | Capsule; Oral | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Fludeoxyglucose F18 | fludeoxyglucose f-18 | Injectable; Intravenous | Houston Cyclotron | Approval |
| Gonal-F | follitropin alfa/beta | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Gonal-F | follitropin alfa/beta | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Gonal-F Rff | follitropin alfa/beta | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Gonal-F Rff Pen | follitropin alfa/beta | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Pristiq | desvenlafaxine succinate | Tablet, Extended Release; Oral | Wyeth Pharms Inc | Efficacy Supplement with Clinical Data to Support |
| Pristiq | desvenlafaxine succinate | Tablet, Extended Release; Oral | Wyeth Pharms Inc | Labeling Revision |
| Rythmol Sr | propafenone hydrochloride | Capsule, Extended Release; Oral | Glaxosmithkline Llc | Labeling Revision |
| Sancuso | granisetron | Film, Extended Release; Transdermal | Prostrakan Inc | Manufacturing Change or Addition |
| Selzentry | maraviroc | Tablet; Oral | Viiv Hlthcare | Labeling Revision |
| Ursodiol | ursodiol | Tablet; Oral | Par Pharm Inc | Approval |
| Valsartan; Hydrochlorothiazide | valsartan; hydrochlorothiazide | Tablet; Oral | Alembic Ltd | Tentative Approval |
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