FDA Approves the First Generic Versions of Ondansetron

ROCKVILLE, Maryland—The US Food and Drug Administration (FDA) has approved the first generic versions of Zofran (ondansetron, GlaxoSmithKline). Marketing approval has been granted to Teva Pharmaceuticals USA for ondansetron for injection and to SICOR Pharmaceuticals for ondansetron injection premixed.

Ondansetron is used to prevent the nausea and vomiting that accompany initial and subsequent courses of emetogenic cancer chemotherapy and for the prevention of postoperative nausea and vomiting. FDA first approved Zofran in 1991. The agency said GlaxoSmithKline agreed to waive the remainder of its 6-month exclusivity period on Zofran to permit approval of the applications submitted for ondansetron by Teva and SICOR.

Teva will manufacture ondansetron for injection and package the drug in single-dose (4 mg/2 mL) and multidose (40 mg/20 mL) vials. SICOR will produce ondansetron injection premixed packaged as 32 mg/50 mL in 5% dextrose. SICOR is a wholly owned subsidiary of Teva.

In announcing the approval of generic ondansetron, FDA emphasized the economic savings that the two versions will bring to patients and the health care system. "According to the online magazine Drug Topics, Zofran was the 20th most expensive brand-name drug used in hospitals in the United States in 2005, with total costs of $839.25 million," FDA said.

Generic drug products are used to fill more than 50% of all prescriptions and can cost a fraction of the price of the brand name drugs. Competition from generic drugs that are safe and effective alternatives to brand name drugs may quickly lead to reductions in cost.