Teva’s ondansetron product is the generic equivalent of GlaxoSmithKline’s antiemetic Zofran injection. Teva believes that its generic equivalent will save customers money as Zofran is one of the more expensive drugs on the market.
The FDA also said that GlaxoSmithKline consented to the approval of Teva’s generic ondansetron by terminating a six-month exclusivity period. Teva and GlaxoSmithKline had previously settled a patent dispute relating to Zofran.
The agency approved three versions of the ondansetron product. The three configurations had annual sales of approximately $695 million for the 12 months ended September 2006, based on IMS sales data.
Teva said that shipment of these products will begin immediately.