New and Generic Drug Approvals
April 17, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Atripla | efavirenz; emtricitabine; tenofovir disoproxil fumarate | Tablet; Oral | Gilead | Labeling Revision |
| Binosto | alendronate sodium | Tablet, Effervescent; Oral | Mission Pharma | Manufacturing Change or Addition |
| Dobutamine Hydrochloride In Dextrose 5% In Plastic Container | dobutamine hydrochloride | Injectable; Injection | Baxter Hlthcare | Labeling Revision |
| Foradil | formoterol fumarate | Powder; Inhalation | Novartis | Manufacturing Change or Addition |
| Glimepiride | glimepiride | Tablet; Oral | Indoco Remedies | Approval |
| Solodyn | minocycline hydrochloride | Tablet, Extended Release; Oral | Medicis | Manufacturing Change or Addition |
| Vimpat | lacosamide | Tablet; Oral | Ucb Inc | Labeling Revision |
| Vimpat | lacosamide | Solution; Intravenous | Ucb Inc | Labeling Revision |
| Vimpat | lacosamide | Solution; Oral | Ucb Inc | Labeling Revision |
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