New and Generic Drug Approvals

Drug Name Active IngredientDosage Form/Route SponsorSubmission Type
Actiq fentanyl citrateTroche/Lozenge;Transmucosal CephalonManufacturing Change or Addition
Altoprev lovastatinTablet, Extended Release;Oral Andrx Labs LlcLabeling Revision
Besivance besifloxacin hydrochlorideSuspension/Drops;Ophthalmic Bausch and LombManufacturing Change or Addition
Cardene nicardipine hydrochlorideInjectable;Injection Ekr TherapManufacturing Change or Addition
Cardene In 0.83% Sodium Chloride In Plastic Container nicardipine hydrochlorideInjectable;Intravenous Ekr TherapManufacturing Change or Addition
Cardene In 0.86% Sodium Chloride In Plastic Container nicardipine hydrochlorideInjectable;Intravenous Ekr TherapManufacturing Change or Addition
Cardene In 4.8% Dextrose In Plastic Container nicardipine hydrochlorideInjectable;Intravenous Ekr TherapManufacturing Change or Addition
Cardene In 5.0% Dextrose In Plastic Container nicardipine hydrochlorideInjectable;Intravenous Ekr TherapManufacturing Change or Addition
Eliquis apixabanTablet;Oral Bristol Myers SquibbManufacturing Change or Addition
Ellipta umeclidinium bromidePowder;Inhalation Glaxo Grp LtdApproval
Epi E Z Pen Jr epinephrineInjectable;Intramuscular Mylan SpecltLabeling Revision
Epipen epinephrineInjectable;Intramuscular, Subcutaneous Mylan SpecltLabeling Revision
Epipen E Z Pen epinephrineInjectable;Intramuscular Mylan SpecltLabeling Revision
Epipen Jr. epinephrineInjectable;Intramuscular, Subcutaneous Mylan SpecltLabeling Revision
Gilenya fingolimodCapsule;Oral NovartisLabeling Revision
Nicoderm Cq nicotineFilm, Extended Release;Transdermal Sanofi Aventis UsLabeling Revision
Soliris eculizumabInjectable; Iv (Infusion) Alexion PharmEfficacy Supplement with Clinical Data to Support
Soliris eculizumabInjectable; Iv (Infusion) Alexion PharmLabeling Revision
Xenical orlistatCapsule;Oral Hoffmann La RocheManufacturing Change or Addition

 

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