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New and Generic Drug Approvals


August 31, 2012
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Azelastine Hydrochlorideazelastine hydrochlorideSpray, Metered; NasalApotex IncApproval
ExelonrivastigmineFilm, Extended Release; TransdermalNovartisEfficacy Supplement with Clinical Data to Support
FelbatolfelbamateSuspension; OralMeda PharmsLabeling Revision
FelbatolfelbamateTablet; OralMeda PharmsLabeling Revision
Mirapexpramipexole dihydrochlorideTablet; OralBoehringer IngelheimEfficacy Supplement with Clinical Data to Support
Mirapex Erpramipexole dihydrochlorideTablet, Extended Release; OralBoehringer IngelheimEfficacy Supplement with Clinical Data to Support
VinorelbinevinorelbineInjectable; InjectionOnco Therapies LtdApproval
XtandienzalutamideCapsule; OralMedivationApproval

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