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Mylan gets tentative approval for Ondansetron HCl Tablets

PittsburghMonday, August 29, 2005, 08:00 Hrs  [IST]

Mylan Pharmaceuticals Inc. has received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Ondansetron Hydrochloride Tablets, 4 mg, 8 mg, 16 mg, and 24 mg. Ondansetron HCl Tablets are the generic version of GlaxoSmithKline's Zofran Tablets, which had annual sales of approximately $600 million, based on IMS data, for the 12 month period ended June 30, 2005.

 
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