April 13, 2010 (FinancialWire) — Mylan Inc. (NASDAQ: MYL) said that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for its generic version of GlaxoSmithKline's (NYSE: GSK) antidepressant Wellbutrin SR.

The official name for Mylan’s version is Bupropion Hydrochloride Extended-Release Tablets USP, (SR), in 100 milligram, 150 mg and 200 mg doses.

Mylan points out that Bupropion Hydrochloride Extended-Release Tablets had U.S. sales of around $363 million for the 12 months ending December 31, 2009, according to IMS Health. Mylan said it has started shipping this product.

The company currently 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.

Pennsylvania-based Mylan is a generic and specialty pharmaceutical firm that provides products in more than 140 countries and territories.

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