Sun Pharma announces USFDA approval to market generic Exelon® Capsules
2007-10-23 · 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 Exelon® Capsules Company gets yet another 180 day marketing exclusivity on a first-to-file ANDA with para IV certification Mumbai, October 23, 2007: 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 Novartis Exelon®, rivastigmine tartrate capsules. These generic rivastigmine capsules are AB-rated equivalent of Novartis Exelon ® Capsules and include four strengths: 1.5 mg (base), 3 mg (base), 4.5 mg (base) and 6 mg (base). These strengths of Exelon ® have annual sales of approximately USD 200 million in the US. Sun Pharma, being one of the first-to-file an ANDA for generic Exelon ® with a para IV certification, shares a 180- day marketing exclusivity. In view of the ongoing liti gation with Novartis on th is product, the Company is evaluating all its launch options. Rivastigmine tartrate is indicated for the treatment of m ild to moderate dementia of the Alzheimer's type and for the treatment of mild to moderate dementia associated with Parkinson’s disease. Exelon ® is a registered trademark of Novartis. About Sun Pharma Established in 1983, listed since 1994 and headquartered in Indi a, Sun Pharma (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, neur ology, cardiology, diabetology, gastroenterology, 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 6645 5605 Tel Direct +91 22 6645 5606 Mobile +91 98670 10529 Mobile +91 98219 23797 E mail [email protected] E mail [email protected]
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