CDER New July 9, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

July 8, 2014

New and Generic Drug Approvals

July 7, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Desvenlafaxine desvenlafaxine Tablet, Extended Release;Oral Alembic Pharms Ltd Labeling Revision
Effexor Xr venlafaxine hydrochloride Capsule, Extended Release;Oral Wyeth Pharms Inc Labeling Revision
Indium In-111 Oxyquinoline indium in-111 oxyquinoline Injectable;Injection Ge Healthcare Manufacturing Change or Addition
Kerydin tavaborole Solution;Topical Anacor Pharms Inc Approval
Marqibo Kit vincristine sulfate Injectable, Liposomal;Intravenous Talon Therap Manufacturing Change or Addition
Telmisartan telmisartan Tablet; Oral Glenmark Generics Approval
Telmisartan telmisartan Tablet; Oral Alembic Ltd Approval
Telmisartan telmisartan Tablet;Oral Mylan Pharms Inc Approval
Telmisartan telmisartan Tablet;Oral Torrent Pharms Approval


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