Sun Pharma announces USFDA approval for generic Astelin® Nasal Spray
2012-05-24 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. 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 Astelin® Nasal Spray Mumbai, May 24, 2012: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) announced that the USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) for its generic version of Astelin ®, Azelastine HCL Nasal Spray, 0.1% (137 mcg/spray). This generic Azelastine HCL Nasal Spray, 0.1% (137 mcg/spray) is therapeutically equivalent to Astelin ® Nasal Spray from Medpointe Pharm HLC. Azelastine HCL nasal sp ray has annual sales of approximately $ 144 million in the US. Azelastine HCL Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing and nasal pruritus; and the symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults and children 12 years and older. Astelin ® is a registered trademark of Medpointe Pharm HLC (Medpointe) About Sun Pharmaceutical Industries Ltd. Established in 1983, listed since 1994 and headquartered in Indi a, Sun Pharmaceutical Indust ries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an internat ional, 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, gastroenterology, ophthalmology and orthopedics. Th e company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosa ge forms. More information abou t 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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