Healthcare Industry News:  osteoporosis 

Biopharmaceuticals Generics FDA

 News Release - September 12, 2008

Sun Pharma Gets USFDA Approval for Generic Fosamax (R) Tablets

MUMBAI, India, September 12 (HSMN NewsFeed) -- Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for generic Fosamax , alendronate sodium tablets.

Alendronate sodium tablets are indicated for the treatment and prevention of osteoporosis in post menopausal women, to increase bone mass in men with osteoporosis, in the treatment of glucocorticoid induced osteoporosis, and Paget's disease of the bone in men and women.

These generic versions of alendronate sodium tablets 5 mg (base), 10 mg (base), 35 mg (base) and 70 mg (base) are bio-equivalent to Fosamax tablets distributed by Merck & Co.

These strengths of Fosamax tablets have annual sales of approximately USD 560 million in the US.

These products will reach market shortly.

Fosamax is a registered trademark of Merck & Co.

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 http://www.sunpharma.com.


Source: Sun Pharmaceutical

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