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Ranbaxy gets tentative approval for generic Norvasc

Our Bureau

New Delhi June 20 Ranbaxy Laboratories said it has received tentative US Food and Drug Administration's approval to make and sell generic version of hypertension drug and coronary Norvasc.

The approval is for Amlodipine Besylate tablets of three strengths. According to the Gurgaon-based company, the total annual market sales for the Pfizer's registered drug Norvasc were at $ 2.79 billion.

The drug is prescribed in the treatment of hypertension and can also be used alone or in combination with other anti-hypertensive agents. Amlodipine besylate is also indicated for the symptomatic treatment of chronic stable angina, or pain resulting from insufficient oxygen-rich blood in the heart, claims Ranbaxy.

"This product represents a future opportunity for Ranbaxy and will be launched following final approval from the FDA," said Mr Jim Meehan, Vice-President of Sales and Marketing of the company's Florida-based subsidiary Ranbaxy Pharmaceuticals Inc. American pharma company, Mylan Laboratories won FDA approval for generic Norvasc in October 2005 and has launched its version in March this year.

More Stories on : Regulatory Bodies & Rulings | Ranbaxy Laboratories Ltd | Pharmaceuticals

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