Sun Pharmaceutical announces USFDA approval to market generic Cerebyx ®
2008-03-19 · 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 Pharmaceutical announces USFDA approval to market generic Cerebyx® Mumbai, March 19, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market a ge neric version of Parke Davis’s Cerebyx®, fosphenytoin sodium injection. This fosphenytoin sodium injection USP, 50 mg PE*/ mL, is therapeutically equivalent to Parke Davis’s Cerebyx®, and is available in two packs: 100 mg PE*/ 2 mL and 500 mg PE*/ 10 mL single dose vials. (PE*= Phenytoin sodium equivalents). Fosphenytoin sodium injection has annual sales of approximately USD 15 million in the US. Fosphenytoin sodium is used for the control of generalized convulsive status epilepticus as well as for prevention and treatment of seizures occurring during neurosurgery. This product will reach the market shortly. Cerebryx® is a registered trademark of Pfizer Inc. 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 international, 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, gastro enterology, 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. 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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