Press release from Business Wire India
Source: Sun Pharmaceuticals Industries Ltd
Tuesday, September 28, 2010 05:18 PM IST (11:48 AM GMT)
Editors: General: Consumer interest; Business: Advertising, PR & marketing, Business services, Healthcare, biotechnology & pharmaceutical; Healthcare
Sun Pharma Announces USFDA Tentative Approval for Generic Rilutek®

Mumbai, Maharashtra, India, Tuesday, September 28, 2010 — (Business Wire India) — Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Sanofi Aventis’s Rilutek® tablets 50 mg.

These generic Riluzole Hydrochloride tablets contain Riluzole Hydrochloride 50 mg. Riluzole Hydrochloride tablets are indicated in the treatment of amyotrophic lateral sclerosis.

Rilutek has annual sale of approximately $ 50 million in the US.

Rilutek® is a registered trademark of Sanofi Aventis US

About Sun Pharmaceutical Industries Ltd.

Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopedics. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. More information about the company can be found at

Uday Baldota, Sun Pharmaceuticals Industries Ltd, +91 (22) 66455645, Xtn 605/ +91 9867010529, [email protected]
Mira Desai, Sun Pharmaceuticals Industries Ltd, +91 (22) 66455645, Xtn 606/ +91 9821923797, [email protected]


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