Sun Pharma announces USFDA tentative approval for generic Cymbalta®
2010-11-24 · 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 tentative approval for generic Cymbalta® Mumbai, November 24, 2010: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary a tentative approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Cymbalta®, duloxetine hydrochloride delayed-release capsules. These generic duloxetine hydrochloride delayed-release capsules, 20 mg (base), 30 mg (base), and 60 mg (base) are indicated in the treatment of Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD) and Diabetic Peripheral Neuropathic Pain (DPNP) Cymbalta® has annual sale of approximately $ 3 billion in the US. Cymbalta® is a registered trademark of Eli Lilly & Company About Sun Pharmaceutical Industries Ltd. Established in 1983, listed since 1994 and headquartered in India, 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 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, orthopedics and ophthalmology. 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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