USFDA: New and Generic Drug Approvals: 16 OCT 2014

New and Generic Drug Approvals

October 16, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Argatroban argatroban Injectable;Injection Hikma Pharm Co Ltd Manufacturing Change or Addition
Cymbalta duloxetine hydrochloride Capsule, Delayed Rel Pellets;Oral Lilly Efficacy Supplement with Clinical Data to Support
Fiorinal aspirin; butalbital; caffeine Capsule;Oral Watson Labs Inc Manufacturing Change or Addition
Fiorinal aspirin; butalbital; caffeine Tablet;Oral Watson Labs Inc Manufacturing Change or Addition
Hylenex Recombinant hyaluronidase recombinant human Injectable;Injection Halozyme Therap Manufacturing Change or Addition
Ilaris canakinumab Injectable; Subcutaneous Novartis Pharms Labeling Revision
Indocin indomethacin Suspension;Oral Iroko Pharms Manufacturing Change or Addition
Lialda mesalamine Tablet, Delayed Release;Oral Shire Labeling Revision
Megace Es megestrol acetate Suspension;Oral Par Pharm Manufacturing Change or Addition
Vascepa icosapent ethyl Capsule;Oral Amarin Pharms Manufacturing Change or Addition
Xeloda capecitabine Tablet;Oral Hoffmann La Roche Labeling Revision

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