US FDA clears Mylan's generic versions of Hyzaar and Cozaar and Watson's copy of Lotrel; Watson settles with Endo

US drugmaker Mylan (Nasdaq: MYL) has received final approvals from the US Food and Drug Administration for its Abbreviated New Drug Applications (ANDAs) for the generic versions of drug giant Merck & Co (NYSE: MRK) antihypertensives Hyzaar (losartan, potassium and hydrochlorothiazide) 50mg/12.5 mg and 100mg/25mg tablets, and Cozaar (losartan potassium) 25mg, 50mg and 100mg.

The drugmaker from Canonsburg, Pa., has now received marketing approval for several doses of the drugs, but it was not able to sell them until this month. Its competitor, Isreal’s Teva Pharmaceutical Industries, was the first company to file for approval of generic versions of the drug, so other versions were barred from the market for six months. Teva received FDA clearance in April.

Losartan potassium and HCTZ Tablets, 50mg/12.5mg and 100mg/25mg, had US sales of around $570 million and losartan potassium of about $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 100mg/12.5 mg strength of losartan potassium and HCTZ tablets on April 6 this year.