Sun Pharma announces USFDA approval for generic Keppra® Injection, levetiracetam® injection
2010-06-17 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗
17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (East), Mumbai 400 093 India Tel.: (91-22) 6645 5645 Fax.: (91-22) 6645 5685 Registered Office : SPARC, Tandalja, Vadodara – 390 020. India Corporate Office : Acme Plaza, Andheri – Kurla Road, Andheri (East), Mumbai – 400 059. India FOR IMMEDIATE RELEASE Sun Pharma announces USFDA approval for generic Keppra ® Injection Mumbai, June 17, 2010: Sun Pharma announced that USFD A 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 th e treatment of myoclonic seizures in patients with Juvenile myoclonic epilepsy. This injection is an alternative fo r 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 Indi a, Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an intern ational, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulat ions as branded generics as well as generics in India, US and several other markets across the world. In India, the compan y 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 abou t the company can be found at www.sunpharma.com. Contacts Uday Baldota Mira Desai Tel +91 22 6645 5645, Xtn 605 Tel +91 22 6645 5645, Xtn 606 Tel Direct +91 22 66455605 Tel Direct +91 22 66455606 Mobile +91 98670 10529 Mobile +91 98219 23797 E mail [email protected] E mail [email protected]
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