Teva's ondansetron ANDA approved
Israel-headquartered generics giant Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted approval for its Abbreviated New Drug Applications to market ondansetron HCl tablets, 4mg, 8mg and 24mg and orally-disintegrating tablets USP, 4mg and 8mg. Teva has commenced shipment of these products.
Teva's ondansetron is the AB-rated generic equivalents of GlaxoSmithKline's Zofran and Zofran ODT, which are indicated for prevention of nausea and vomiting in patients undergoing chemotherapy, radiation therapy, or surgery.
Total annual sales of ondansetron HCl tablets and ODT tablets, including brand and generic sales, are approximately $750.0 million and $350.0 million, respectively, in the USA for the 12 months ended March 2007, based on IMS Heath data.
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