Ranbaxy gains final FDA approval for quinapril + HCTZ
India-based generics major Ranbaxy Laboratories says its US subsidiary has received approval from the Food and Drug Administration to manufacture and market quinapril hydrochloride and hydrochlorothiazide 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 of the FDA has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Accuretic tablets of Pfizer. Total annual market sales for Quinapril + HCTZ tablets were $29.0 million, in 2008, according to IMS Health data.
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