Business Advancement: Mylan Wins FDA Nod
October 18, 2010 (FinancialWire) (http://www.financialwire.net/) – Mylan Inc. (NASDAQ: MYL) said that its subsidiary Mylan Pharmaceuticals Inc. has received final approvals from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications (ANDAs) for the generic versions of Hyzaar Tablets, 50 mg/12.5 mg and 100 mg/25 mg, and Cozaar Tablets, 25 mg, 50 mg and 100 mg, both antihypertensives.
Merck and Co. Inc.'s Hyzaar is known generically as Losartan Potassium and Hydrochlorothiazide Tablets and Merck Research Laboratories' Cozaar is known generically as Losartan Potassium Tablets.
Losartan Potassium and HCTZ Tablets, 50 mg/12.5 mg and 100 mg/25 mg, had U.S. sales of around $570 million and Losartan Potassium Tablets had U.S. sales of around $940 million for the 12 months ending June 30, 2010, according to IMS Health.
Both products are available for immediate shipment, according to Mylan.
Mylan Pharmaceuticals received final FDA approval and launched the 100 mg/12.5 mg strength of Losartan Potassium and HCTZ Tablets on April 6.
Currently, Mylan has 151 ANDAs pending FDA approval.
Pennsylvania-based Mylan is a generic and specialty pharmaceutical firm that provides products to customers in more than 140 countries and territories.
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