Mylan Pharmaceuticals receives FDA approval for Bupropion HCl ER Tablets

May 4 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), 150 mg, the generic version of GlaxoSmithKline's smoking cessation aid, Zyban®.  

Bupropion HCl ER Tablets had U.S. sales of approximately $9.7 million for the 12 months ending Dec. 31, 2009, according to IMS Health. The product is available for immediate shipment.

Currently, Mylan has 140 ANDAs pending FDA approval representing $96.5 billion in annual brand sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $19.6 billion in annual brand sales, for the 12 months ending Dec. 31, 2009, according to IMS Health.