Sun Pharma announces USFDA approval for generic Uroxatral® ER tablets Company gets 180 day marketing exclusivity on first-to-file ANDA with para IV certification
2011-07-19 · 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 Pharma announces USFDA approval for generic Uroxatral® ER Tablets Company gets 180 day marketing exclusivity on first-to-file ANDA with para IV certification Mumbai, July 19, 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 Uroxatral ® ER, alfuzosin hydrochloride extended release tablets. Sun Pharma, being the first-to file an ANDA for generic Uroxatral® ER with a para IV certification, received a 180 day marketing exclusivity. These alfuzosin hydrochloride 10 mg tablets are therapeutically equivalent to Uroxatal Extended Release ® tablets from sanofi-aventis. Alfuzosin hydrochloride extended release tablets have annual sales of approximately USD 250 million in US. Alfuzosin is an alpha 1 blocker for the treatment of signs and symptoms of benign prostatic hyperplasia. Uroxatral ® is a registered trademark of Sanofi-Aventis U.S. LLC. 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 internat ional, 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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