Sun Pharma announces USFDA approval to market generic Topamax® tablets
2009-03-28 · 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 Topamax ® tablets Mumbai, March 28, 2009: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA ha s granted an approval for its Abbreviated New Drug Application (ANDA) to market generic Topamax ®, topiramate tablets. These topiramate tablets are therapeutically equivale nt to Topamax® tablets from Ortho-McNeil Janssen Pharmaceuticals, Inc. and are available in four strengths: 25 mg, 50 mg, 100 mg, and 200 mg. These strengths of Topamax® tablets have annual sales of approximately USD 2.5 billion in the US. Topiramate, an anticonvulsant is indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. It is also indicated as adjunctive therapy for adults and pediatric patients ages 2-16 years with partial onset seiz ures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome. Shipment of this product has commenced. Topamax® is a registered trademark of Ortho-McNeil Janssen 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 international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulat ions as branded generics as well as generics in India, US and several other markets across the world. In India, the compan y is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastro enterology, 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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