The FDA approved the first generic version of injectable ondansetron on November 22, 2006. Previously ondansetron was only available as the brand-name drug Zofran®.
Ondansetron is indicated to prevent nausea and vomiting during chemotherapy and to prevent nausea and vomiting after surgery
Approval is for injectable ondansetron manufactured by TEVA Pharmaceuticals and premixed ondansetron injections manufactured by SICOR Pharmaceuticals.
Gary J. Buehler, Director of the FDA Office of Generic Drugs, said,
These approvals will result in significant savings for the American public. Generic drugs undergo a thorough scientific and regulatory review, and are safe and effective alternatives to brand name drugs.
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