Sun Pharma announces USFDA approval for generic Keppra ® Injection
Mumbai, June 17, 2010: 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.
You have received this email as your address is part of our Investor Relations and Media Contacts list. All our Press Releases and Financial updates are sent to those on the list.
- If you wish to be removed from this list or your address has been accidentally included here, then please let us know by a return email and we will remove it. All the others will continue to be on the mailing list.
- If you wish to receive emails on some other email id, please send it to us.
- If you think that somebody else from your organisation should be added to this list, then please ask him / her to send us an email and we will add.
- If you are changing jobs, please send us your new email id. We would like to be in touch with you and keep you updated on happenings at Sun Pharma.
