Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals
Inc. received final approvals from the FDA
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 (HCTZ) 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
approximately $570 million and Losartan Potassium Tablets had U.S. sales of
approximately $940 million for the 12 months ending June 30, 2010, according to
IMS Health. Both products are available for immediate shipment. Mylan Pharmaceuticals
received final FDA approval and launched the 100 mg/12.5 mg strength of
Losartan Potassium and HCTZ Tablets on April 6, 2010.