Mylan Receives FDA Approval for Hyzaar Generics

14 April 2010 (Last Updated April 14th, 2010 18:30)

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 Hy

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.