FDA gives tentative approval to Dr. Reddy's hypertension drug

FDA grants tentative approval for valsartan tablets to Indian drug maker

 SILVER SPRING, Md. - The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

The FDA granted tentative approval to Dr. Reddy's Labs' valsartan tablets in the 40 mg, 80 mg, 160 mg and 320 mg strengths.

The drug is a generic version of Novartis' Diovan. Various versions of the drug had sales of $1.6 billion during the 12-month period that ended in June, according to IMS Health.

Tentative approval means that a drug meets the FDA's conditions for approval, but the agency can't give it final approval due to patent or exclusivity issues. 

In early January 2013, the U.S. District Court for the District of Columbia upheld an FDA decision protecting Ranbaxy Labs' market exclusivity for its generic valsartan tablets.


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