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news.Mylan Pharmaceuticals has received tentative approval from the FDA for its abbreviated new drug application for ondansetron hydrochloride tablets, 4 mg, 8mg, 16mg, and 24mg, for the treatment of nausea and vomiting.
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Ondansetron HCl tablets are the generic version of GlaxoSmithKline’s Zofran, which had annual sales of approximately $600 million.
The approval from the FDA for Mylan’s generic version of the drug signals that the agency is happy with the safety and efficacy of the Mylan version, but the company will have to wait until Glaxo’s patent on the drug expires at the end of 2006.
Mylan Laboratories is a pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals, Mylan Technologies and UDL Laboratories, that develop, license, manufacture, market and distribute an extensive line of generic and proprietary products.