Mylan Inc. has been cleared by the Food and Drug Administration to market nifedipine extended-release tablets for the treatment of hypertension.


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Mylan gets approval for generic Adalat CC

December 10th, 2010

PITTSBURGH – Mylan Inc. has been cleared by the Food and Drug Administration to market nifedipine extended-release tablets for the treatment of hypertension.

The company said Friday that its Mylan Pharmaceuticals Inc. subsidiary has received final approval from the FDA for its abbreviated new drug application (ANDA) for nifedipine extended-release tablets USP in 30-mg, 60-mg and 90-mg dosages.

Mylan said the antihypertensive is the generic version of Bayer's Adalat CC Tablets.

Nifedipine tablets had U.S. sales of approximately $82 million for the 12 months ended June 30, according to IMS Health data cited by Mylan.

Nifedipine is a calcium channel blocker that dilates blood vessels to make it easier for the heart to pump blood, in turn reducing its workload. The drug is used in the treatment of high blood pressure and angina.

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