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 Applications (ANDA) for Losartan Potassium and Hydrochlorothiazide (HCTZ) tablets 100 mg/12.5 mg, the generic version of Merck and Co, Inc's antihypertensive Hyzaar and Bupropion Hydrochloride Extended-Release tablets USP, (SR), 100 mg, 150 mg and 200 mg, the generic version of GlaxoSmithKline's antidepressant Wellbutrin SR.

Losartan Potassium and HCTZ tablets had US sales of approximately US$ 695 million for the 12 months ending December 31, 2009, according to IMS Health, for all strengths and US$ 93.8 million for the 100mg/12.5 mg strength, which Mylan has started to ship.

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

Currently, Mylan has 141 ANDAs pending US FDA approval representing US$ 96.2 billion in annual brand sales, according to IMS Health. Thirty-eight of these pending ANDAs are potential first-to-file opportunities, representing US$19.8 billion in annual brand sales, for the 12 months ending December 31, 2009, according to IMS Health.