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Ranbaxy gets USFDA nod for high BP drug
March 05, 2009 19:19 IST
Drug-maker Ranbaxy Laboratories [Get Quote] on Thursday said it has received the US health regulator's approval to market Quinapril Hydrochloride and Hydrochlorothiazide tablets, used in treatment of high blood pressure, in different strengths in America.
In a filing to the Bombay Stock Exchange, Ranbaxy said it got the approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Quinapril Hydrochloride and Hydrochlorothiazide tablets.
The application for the drug had been submitted by Ranbaxy's arm OHM Laboratories manufacturing facility, at New Jersey, USA.
The Office of Generic Drugs, USFDA, had determined the Ranbaxy formulations to be bioequivalent of Accuretic Tablets of Pfizer [Get Quote] Pharmaceuticals, it added. Quilapril Hydrochloride and Hydrochlorothiazide are the generic version of Pfizer Pharmaceuticals 's Accurctic tablets, the company said.
These tablets will be available in the strength of 10mg or 12.5mg, 20mg or 12.5mg and 20mg or 25mg in the US market. This is the second ANDA from USFDA to Ranbaxy in the last two months.