BWI: Sun Pharma Announces USFDA Approval For Generic Keppra ® Injection

Press release from Business Wire India
Source: Sun Pharmaceuticals Industries Ltd
Thursday, June 17, 2010 02:49 PM IST (09:19 AM GMT)
Editors: General: Consumer interest; Business: Healthcare, biotechnology & pharmaceutical, Law firms, Stock exchanges; Healthcare
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Sun Pharma Announces USFDA Approval For Generic Keppra ® Injection


Mumbai, Maharashtra, India, Thursday, June 17, 2010 -- (Business Wire India) -- Sun Pharma announced that USFDA has granted an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Keppra ® Injection, levetiracetam injection.

This generic levetiracetam injection, 100 mg/ml packaged in 500 mg / 5 ml single use vials, is equivalent to UCB's Keppra® Injection 100 mg/ml. Annual sale in US for levetiracetam injection is estimated at $ 85 million.

Levetiracetam injection is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. It is also indicated as adjunctive therapy in the treatment of myoclonic seizures in patients with Juvenile myoclonic epilepsy. This injection is an alternative for patients when oral administration is temporarily not feasible.

The Company expects to reach the market shortly with this product.

Keppra® is a registered trademark of UCB.


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, orthopedics and ophthalmology. 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, Ext 605 / +91 22 66455605 / +91 98670 10529, uday.baldota@sunpharma.com
Mira Desai, Sun Pharmaceuticals Industries Ltd, +91 22 66455606 / +91 98219 23797, mira.desai@sunpharma.com

KEYWORDS
CONSUMER, HEALTHCARE, LAW FIRMS, STOCK EXCHANGES, HEALTHCARE, 524715.BO, SUNPHARMA .NS

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