New and Generic Drug Approvals
December 4, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acuvail | ketorolac tromethamine | Solution/Drops;Ophthalmic | Allergan | Labeling Revision |
| Idamycin | idarubicin hydrochloride | Injectable;Injection | Pharmacia and Upjohn | Labeling Revision |
| Idamycin Pfs | idarubicin hydrochloride | Injectable;Injection | Pharmacia and Upjohn | Labeling Revision |
| Jakafi | ruxolitinib phosphate | Tablet;Oral | Incyte Corp | Efficacy Supplement with Clinical Data to Support |
| Lastacaft | alcaftadine | Solution/Drops;Ophthalmic | Allergan | Labeling Revision |
| Mozobil | plerixafor | Solution;Subcutaneous | Genzyme | Labeling Revision |
| Pamidronate Disodium | pamidronate disodium | Injectable;Injection | Eurohlth Intl | Labeling Revision |
| Vizamyl | flutemetamol f-18 | Injectable;Intravenous | Ge Healthcare | Labeling Revision |
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