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Teva gets go-ahead from FDA for generic Zofran
By Adam Kraemer,
Drug Store News
Tuesday, July 10, 2007
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Teva Pharmaceutical Industries announced that the Food and Drug Administration has granted approval to market ondansetron hydrochloride tablets, 4 mg, 8 mg and 24 mg, and ondansetron orally disintegrating tablets USP, 4 mg and 8 mg.
Teva's ondansetron products are AB-rated generic equivalents of GlaxoSmithKline's Zofran tablets and Zofran ODT, which are indicated for prevention of nausea and vomiting in patients undergoing chemotherapy, radiation therapy or surgery.
Total annual U.S. sales of ondansetron hydrochloride tablets and ondansetron ODT, including brand and generics, for the twelve months ended March 2007, are approximately $750 million and $350 million, respectively, based on IMS data.
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