drugset / Press release

Sun Pharma announces USFDA approval to market generic Roxicodone® tablets.

2009-04-13 · 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 to market generic Roxicodone® tablets Mumbai, April 13, 2009: 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 generic Roxicodone ®, oxycodone hydrochloride tablets. These oxycodone tablets are therapeutically equivalent to Roxicodone® tablets from Xanodyne Pharmaceuticals Inc., and are available in three strengths: 5 mg, 15 mg and 30 mg. These strengths of oxycodone tablets have annual sales of approximately USD 160 million in the US. Oxycodone is a narcotic painkiller used in the treatment of moderate to severe pain. This product will reach the market shortly. Roxicodone® is a registered trademark of Xanodyne Pharmaceuticals, 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]

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