FDA APPROVES FIRST GENERIC ONDANSETRON

Pharmacy Times, Volume 0, 0

The FDA recently approved thefirst generic versions of Zofran(ondansetron) Injection and Zofran(ondansetron) InjectionPremixed, drugs used to preventnausea and vomiting in chemotherapypatients.

Indicating that Zofran rankedamong the 20 most expensivebrand name drugs used in UShospitals during 2005, FDAGeneric Drug Office DirectorGary J. Buehler predicted thatthe approvals "will result in significantsavings for the Americanpublic."

According to the FDA, ondansetroninjection is packagedin single (4 mg/2 mL) and multidose(40 mg/20 mL) vials madeby Teva Pharmaceuticals USA.Ondansetron Injection Premixed,32 mg/50 mL in 5% dextrose, ismade by SICOR PharmaceuticalsInc. GlaxoSmithKline, maker ofthe innovator drug, has agreedto waive the remainder of a 6-month exclusivity period.