Ranbaxy secures FDA approval for quinapril hydrochloride + hydrochlorothiazide tablets

Mar 5 2009

Ranbaxy Pharmaceuticals has announced approval from the U.S. Food and Drug Administration to manufacture and market Quinapril Hydrochloride & Hydrochlorothiazide (Quinapril + HCTZ) Tablets, 10mg/12.5mg, 20mg/12.5mg and 20mg/25mg.

The Application for the drug was submitted by Ranbaxy, from its Ohm Laboratories manufacturing facility located in North Brunswick, New Jersey. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Accuretic(R) Tablets of Pfizer Pharmaceuticals Ltd. Total annual market sales for Quinapril + HCTZ Tablets were $29 million (IMS - MAT: December 2008).

According to Jim Meehan, Vice President of Sales and Distribution for RPI, "We are pleased to receive this final approval for Quinapril + HCTZ, an ACE inhibitor that is used to treat high blood pressure. This is the second ANDA approval granted by the FDA, to Ranbaxy, in the last two months. Product will be made available to all classes of trade in the near term."