Sun Pharma announces USFDA approval for generic Imitrex® injection
2011-06-21 · 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 Imitrex® injection First ANDA approval for a Sumatriptan AutoInjector Mumbai, June 21, 2011: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Sumatriptan Succinate Injection, 6 mg (base) / 0.5mL. This is the first ANDA approval for a Sumatriptan AutoInjector. This generic Sumatriptan Succinate Injection packaged in a Single-Dose Syringe with AutoInjector is equivalent to Imitrex® S TATdose S ystem, 6 mg (base) / 0.5 mL of GlaxoSmithKline. Annual sale for Sumatripta n S uccina te Injections in the US is approximately $ 190 million. Sumatriptan succinate injection is indicated for the acute treatment of migraine attacks with or without aura and the acute treatment of cluster headache episodes. Imitrex® is a registered trademark of GlaxoSmithKline. About Sun Pharmaceutical Industries Ltd. Established in 1983, listed since 1994 and headquartered in India, Sun Pharma (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, ophthalmology and nephrology. 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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