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.