drugset / Press release

Generic Eloxatin® and Imitrex® approval: shares 180-day marketing drug exclusivity for generic Eloxatin®

2009-08-11 · 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 Eloxatin® and Imitrex® Shares 180-day marketing drug exclusivity for generic Eloxatin® Mumbai, August 11, 2009: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (collectively with its subsid iaries,”Sun Pharma”) announced that USFDA has granted approvals for two Abbreviated New Drug Applications (AND As), 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 Indi a, Sun Pharmaceutical Indust ries 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]

The release as fetched from its publisher. sunpharma.com ↗