drugset / Press release

Sun Pharma announces USFDA approval for generic Strattera® Capsules

2010-08-31 · 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 Strattera® Capsules Company receives 180 days marketing exclusivity Mumbai, August 31, 2010: 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 Strattera ®, atomoxetine hydrochloride capsules. These generic atomoxetine hydrochloride capsules are equivalent to Eli Lilly’s Strattera ® capsules and include six strengths: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, and 100 mg. Annual sale in US for these strengths of branded and generic atomoxetine hydrochloride capsules is estimated at over $ 530 million. Atomoxetine Hydrochloride capsules are indicated for the management of attention deficit hyperactivity disorder in children aged 6 and older,teens and adults. Stattera® is a registered trademark of Eli Lilly and Co. About Sun Pharma Established in 1983, listed since 1994 and headquartered in In dia, Sun Pharma (Reuters: SUN.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, orthopedics and ophthalmolog y. 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 ↗