Mylan Pharmaceuticals has received the final approval for its abbreviated new drug application (ANDA) for losartan potassium and hydrochlorothiazide (HCTZ) tablets 100mg / 12.5 mg from the US FDA.

Losartan potassium and HCTZ tablets are the generic version of Merck’s antihypertensive Hyzaar, which had $695m sales in the US during 2009, according to IMS Health data.

The FDA has also given tentative approvals for the 50mg / 12.5mg and 100mg / 25mg strength tablets, which are eligible for final approval on or around 4 October 2010, following the completion of the 180-day exclusivity period.