Sun Pharma update on ANDA for generic Effexor XR: USFDA grants Osmotica's citizen petition
2008-11-27 · 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 update on ANDA for generic Effexor XR® Mumbai, November 27, 2008: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) announced that the USFDA has granted Osmotica’s Citizen Petition regarding venlafaxine extended release tablets. In this petiti on, USFDA was requested to refrain from approving any pending Abbreviated New Drug Application (ANDA) for such tablets that cited Wyeth’s Effexor XR® capsules as the reference drug. Sun Pharma had previously filed an ANDA with multiple para IV certifications for generic venlafaxine extended release tablets, bio-equivalent to Effexor XR® capsules . In a communication sent by USFDA to Osmotica, USFDA has concluded that now an ANDA for venlafaxine extended release tablets should reference Osmotica’s product and not Effexor XR®. Additionally, with such amendments to a pending ANDA not being permitted as per USFDA, it has advised the Company to submit a new ANDA if it wishes to pursue approval of an ANDA for venlafaxine extended release tablets. Effexor XR ® is a registered trademark of Wyeth 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 intern ational, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulat ions as branded generics as well as generics in India, U.S. 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 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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