CDER New December 31, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

December 30, 2014


New and Generic Drug Approvals

December 30, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aplenzin bupropion hydrobromide Tablet, Extended Release;Oral Valeant Bermuda Labeling Revision
Lamictal lamotrigine Tablet;Oral Glaxosmithkline Llc Labeling Revision
Lamictal CD lamotrigine Tablet, Chewable;Oral Glaxosmithkline Llc Labeling Revision
Lamictal ODT lamotrigine Tablet, Orally Disintegrating;Oral Glaxosmithkline Llc Labeling Revision
Lamictal XR lamotrigine Tablet, Extended Release;Oral Glaxosmithkline Llc Labeling Revision
Natroba spinosad Suspension;Topical Parapro Llc Efficacy Supplement with Clinical Data to Support
Wellbutrin XL bupropion hydrochloride Tablet, Extended Release;Oral Valeant Intl Labeling Revision

 

December 29, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Gadavist gadobutrol Solution;Intravenous Bayer Hlthcare Efficacy Supplement with Clinical Data to Support
Inlyta axitinib Tablet;Oral Pfizer Labeling Revision
Kalydeco ivacaftor Tablet;Oral Vertex Pharms Efficacy Supplement with Clinical Data to Support
Kalydeco ivacaftor Tablet;Oral Vertex Pharms Labeling Revision
Omeprazole and Clarithromycin and Amoxicillin amoxicillin; clarithromycin; omeprazole Capsule, Tablet, Capsule, Delayed Release;Oral Gastroentero Labeling Revision

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