Generic Hyzaar and Cozaar Approved by FDA

Mylan Pharmaceuticals, Inc. received approval from the FDA for its ANDAs for the generic versions of antihypertensive drugs Hyzaar Tablets, 50 mg/12.5 mg and 100 mg/25 mg, and Cozaar Tablets, 25 mg, 50 mg and 100 mg. Merck’s Hyzaar and Cozaar are known generically as Losartan Potassium and Hydrochlorothiazide (HCTZ) Tablets, and Losartan Potassium Tablets, respectively.

According to IMS Health, the two drugs had U.S. sales of approximately $1.5 billion for the 12 months ending June 30, 2010. Both products are available for immediate shipment. Mylan launched the 100 mg/12.5 mg strength of Losartan Potassium and HCTZ Tablets on April 6, 2010.