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Ranbaxy gets US FDA nod for drug
March 15, 2004 18:29 IST
Ranbaxy Laboratories on Monday said it has received tentative approval from the United States Food and Drug Administration to manufacture and market anti-hypertension drug Quinapril Hydrochloride in the US.
Ranbaxy Pharmaceuticals has received the tentative nod to market the drug in tablets of 5 mg, 10 mg, 20 mg and 40 mg dosages, a company statement said in New Delhi.
Quinapril Hydrochloride has a market size of $632.2 million with Accupril dominating the market with sales of $589 million.
Besides the treatment of hypertension, the drug is also prescribed in the management of heart failure.
Ranbaxy sales and marketing vice-president Jim Meehan said a final approval of the drug will add Quinapril Hydrochloride tablets to "our product portfolio of affordable generic alternatives."
"This product offering in the cardio-vascular class of medications will provide benefits to the US healthcare system, prescribers and patients," he added.