FDA grants final approval for Teva Pharmaceutical Industries' generic Hyzaar and Cozaar

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Apr 8 2010

Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's generic versions of Merck's antihypertensive agents Hyzaar® (hydrochlorothiazide; losartan potassium) and Cozaar® (losartan potassium).

As the first company to file ANDAs that contained a paragraph IV certification for Hyzaar® and Cozaar®: Teva has been awarded 180-day Hatch-Waxman statutory exclusivity to market these products.

The brand products had combined annual sales of approximately $1.6 billion in the United States, based on IMS sales data.

Source:

Teva Pharmaceutical Industries Ltd.,

Posted in: Medical Condition News | Pharmaceutical News

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