FDA APPROVES FIRST GENERIC ONDANSETRON

JANUARY 01, 2007

The FDA recently approved the first generic versions of Zofran (ondansetron) Injection and Zofran (ondansetron) Injection Premixed, drugs used to prevent nausea and vomiting in chemotherapy patients.

Indicating that Zofran ranked among the 20 most expensive brand name drugs used in US hospitals during 2005, FDA Generic Drug Office Director Gary J. Buehler predicted that the approvals "will result in significant savings for the American public."

According to the FDA, ondansetron injection is packaged in single (4 mg/2 mL) and multidose (40 mg/20 mL) vials made by Teva Pharmaceuticals USA. Ondansetron Injection Premixed, 32 mg/50 mL in 5% dextrose, is made by SICOR Pharmaceuticals Inc. GlaxoSmithKline, maker of the innovator drug, has agreed to waive the remainder of a 6-month exclusivity period.




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