BWI: Sun Pharma Announces USFDA Approval for Generic Eloxatin® and Imitrex®

Press release from Business Wire India
Source: Sun Pharmaceuticals Industries Ltd
Tuesday, August 11, 2009 09:50 PM IST (04:20 PM GMT)
Editors: General: Consumer interest; Business: Healthcare, biotechnology & pharmaceutical, Law firms; Healthcare
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Sun Pharma Announces USFDA Approval for Generic Eloxatin® and Imitrex®
Shares 180-day Marketing Drug Exclusivity for Generic Eloxatin®

Mumbai, Maharashtra, India, Tuesday, August 11, 2009 -- (Business Wire India) -- Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (collectively with its subsidiaries,"Sun Pharma") announced that USFDA has granted approvals for two Abbreviated New Drug Applications (ANDAs), generic version of Eloxatin ®, oxaliplatin for injection and generic version of Imtrex ®, sumatriptan succinate tablets. Sun Pharma shares 180 days exclusivity for generic version of Eloxatin®.

These oxaliplatin injections, 50 mg and 100 mg packed in single use vials, are therapeutically equivalent to Eloxatin ® injections from sanofi-aventis. Oxaliplatin injections have annual sales of approximately USD 2.3 billion in the US. Oxaliplatin is an anticancer used in the treatment of colon and rectal cancer.

These sumatriptan succinate tablets, 25 mg (base), 50 mg (base) and 100 mg (base) are therapeutically equivalent to Imitrex® tablets from GlaxoSmithkline. Sumatriptan succinate tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.

Eloxatin® is a registered trademark of sanofi aventis U.S. LLC
Imitrex® is a registered trademark of GlaxoSmithkline.

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 www.sunpharma.com.




CONTACT DETAILS
Uday Baldota, Sun Pharmaceuticals Industries Ltd, +91 22 6645 5645, Xtn 605, +91 22 66455605, Mobile: +91 98670 10529, uday.baldota@sunpharma.com
Mira Desai, Sun Pharmaceuticals Industries Ltd, +91 22 6645 5645, Xtn 606, +91 22 66455606, Mobile: +91 98219 23797, mira.desai@sunpharma.com

KEYWORDS
CONSUMER, HEALTHCARE, LAW FIRMS, HEALTHCARE, SUNPHARMA.BO, SUNPHARMA .NS

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