Mylan Pharmaceuticals' ANDA for generic Wellbutrin SR receives FDA final approval

Apr 12 2010

Mylan Inc. (Nasdaq: MYL) 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^®.  

Bupropion Hydrochloride Extended-Release Tablets had U.S. sales of approximately $363 million for the 12 months ending Dec. 31, 2009, according to IMS Health. Mylan has started shipping this product.

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.