US FDA clears Teva's generic of GSK's Zofran
The the US Food and Drug Administration has cleared a generic version of UK drug major GlaxoSmithKline's Zofran (ondansetron HCl) made by Israel's Teva Pharmaceuticals Industries.
The drug, which will be available in both injectable and premixed injectable formulations, is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (cancer therapy that causes vomiting) and prevention of postoperative nausea and vomiting.
According to the on-line magazine Drug Topics, Zofran was the 20th most expensive brand-name drug used in hospitals in the USA, costing a total of $839.26 million in 2005. Ondansetron injection, packaged in single (4mg/2mL) and multidose (40mg/20mL) vials, is manufactured by Teva Pharmaceuticals USA in North Wales, Pennsylvania. The premixed form, which comes in 32 mg/50mL in 5% dextrose is manufactured by Irvine, California-based Sicor Pharmaceuticals, a Teva subsidiary since November 2003.
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