FDA approves Ranbaxy Labs to manufacture, market generic version of Pfizer’s Accuretic

PRINCETON, N.J. The Food and Drug Administration has given approval to Ranbaxy Labs to manufacture and market a generic version of Pfizer’s Accuretic tablets used to treat hypertension, U.S. subsidiary Ranbaxy Pharmaceuticals announced Thursday.

The Indian generic drug maker will make quinapril hydrochloride and hydrochlorothiazide tablets in the 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg strengths. The branded version of the drug had sales of $29 million for the 12 months ended in December 2008, according to IMS Health data.

“This is the second ANDA approval granted by the FDA to Ranbaxy in the last two months,” Ranbaxy Pharmaceuticals VP sales and distribution Jim Meehan said in a statement, referring to the applications used to get approval for generic drugs. “Product will be made available to all classes of trade in the near term.”