Mylan Inc announced that its subsidiary Mylan Pharmaceuticals Inc received final approval from the US 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 US sales of approximately US$ 9.7 million for the 12 months ending December 31, 2009, according to IMS Health. The product is available for immediate shipment.
Currently, Mylan has 140 ANDAs pending US FDA approval representing US$ 96.5 billion in annual brand sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing US$ 19.6 billion in annual brand sales, for the 12 months ending Dec. 31, 2009, according to IMS Health.