New and Generic Drug Approvals

July 2, 2013

Drug Name Active IngredientDosage Form/Route SponsorSubmission Type
Actemra tocilizumabInjectable; Injection GenentechLabeling Revision
Efudex fluorouracilCream; Topical Valeant Pharm IntlManufacturing Change or Addition
Efudex fluorouracilSolution; Topical Valeant Pharm IntlManufacturing Change or Addition
Nasacort Aq triamcinolone acetonideSpray, Metered; Nasal Sanofi Aventis UsEfficacy Supplement with Clinical Data to Support
Pegasys peginterferon alfa-2aSyringe Hoffman-La RocheLabeling Revision
Pegasys peginterferon alfa-2aVial; Subcutaneous Hoffman-La RocheLabeling Revision
Rosuvastatin Calcium rosuvastatin calciumTablet; Oral Mylan PharmaTentative Approval
Sprix ketorolac tromethamineSpray, Metered; Nasal LuitpoldManufacturing Change or Addition
Ziana clindamycin phosphate; tretinoinGel; Topical MedicisManufacturing Change or Addition

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