PITTSBURGH, April 12 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets USP, (SR), 100 mg, 150 mg and 200 mg, the generic version of GlaxoSmithKline’s antidepressant Wellbutrin SR((R)).
Currently, Mylan has 141 ANDAs pending FDA approval representing $96.2 billion in annual brand sales, according to IMS Health. Thirty-eight of these pending ANDAs are potential first-to-file opportunities, representing $19.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2009, according to IMS Health.
Mylan Inc.
