New and Generic Drug Approvals
July 2, 2013
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Actemra | tocilizumab | Injectable; Injection | Genentech | Labeling Revision |
Efudex | fluorouracil | Cream; Topical | Valeant Pharm Intl | Manufacturing Change or Addition |
Efudex | fluorouracil | Solution; Topical | Valeant Pharm Intl | Manufacturing Change or Addition |
Nasacort Aq | triamcinolone acetonide | Spray, Metered; Nasal | Sanofi Aventis Us | Efficacy Supplement with Clinical Data to Support |
Pegasys | peginterferon alfa-2a | Syringe | Hoffman-La Roche | Labeling Revision |
Pegasys | peginterferon alfa-2a | Vial; Subcutaneous | Hoffman-La Roche | Labeling Revision |
Rosuvastatin Calcium | rosuvastatin calcium | Tablet; Oral | Mylan Pharma | Tentative Approval |
Sprix | ketorolac tromethamine | Spray, Metered; Nasal | Luitpold | Manufacturing Change or Addition |
Ziana | clindamycin phosphate; tretinoin | Gel; Topical | Medicis | Manufacturing Change or Addition |
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