Teva Receives FDA Approval for Antihypertensive Generics

8 April 2010 (Last Updated April 8th, 2010 18:30)

Teva Pharmaceutical Industries has received final approval from the US FDA for its generic versions of Merck’s anti-hypertensive agents Hyzaar (hydrochlorothiazide; losartan potassium) and Cozaar (losartan potassium). Teva has been awarded 180-day Hatch-Waxman statutory exclusivity to m

Teva Pharmaceutical Industries has received final approval from the US FDA for its generic versions of Merck’s anti-hypertensive agents Hyzaar (hydrochlorothiazide; losartan potassium) and Cozaar (losartan potassium).

Teva has been awarded 180-day Hatch-Waxman statutory exclusivity to market the products as it is the first company to file an abbreviated new drug application with the FDA that contained a paragraph IV certification.

Teva said on 2 March the US Court of Appeals for the District of Columbia Circuit has ruled in its favour by overturning a 31 July 2009 district court decision on the 180-day exclusivity.

According to IMS sales data, the products had combined annual sales of $1.6bn in the US.