FDA approves Mylan Pharmaceuticals' ANDA for generic Hyzaar

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 Losartan Potassium and Hydrochlorothiazide (HCTZ) Tablets 100 mg/12.5 mg, the generic version of Merck and Co., Inc.'s antihypertensive Hyzaar^®. Additionally, the company received tentative approval for the 50 mg/12.5 mg and 100 mg/25 mg strengths, which are eligible for final approval on or around Oct. 4, 2010, upon the expiration of the first-to-file 180-day exclusivity period.

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

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 December 31, 2009, according to IMS Health.