drugset / Press release

Sun Pharma gets USFDA approval to market generic Demadex ® Tablets

2008-02-27 · 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 gets USFDA approval to market generic Demadex® Tablets Mumbai, February 27, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) to market its generic version of Hoffman la Roche’s Demadex®, torsemide tablets. These generic torsemide tablets are therapeutic equivalents of Hoffman la Roche’s Demadex® Tablets and include four strengths: 5 mg, 10 mg, 20 mg and 100 mg. These strengths of torsemide tablets have annual sales of approximately USD 35 million in the US. Torsemide is a diuretic, indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Torsemide is also indicated for the treatment of hypertension alone or in combination with other antihypertensive agents. The Company expects to reach the market shortly with these products. Demadex® is a registered trademark of Roche Therapeutics, Inc. About Sun Pharma Established in 1983, listed since 1994 and headquartered in In dia, Sun Pharma (Reuters: SU N.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) is an inte rnational, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as brande d 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, and orthopedics. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage form s. 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 ↗