Ranbaxy gets US FDA nod for drug

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.