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FDA Approves Generic Ondansetron for Injection

Two companies to market generic version of the drug to prevent chemotherapy-related nausea and vomiting

MONDAY, Nov. 27 (HealthDay News) -- The U.S. Food and Drug Administration has approved two generic injected forms of the drug Zofran (ondansetron) to be used for the prevention of nausea and vomiting after chemotherapy or surgery.

Ondansetron Injection is made by Teva Pharmaceuticals USA of North Wales, Pa., and is packaged in single and multidose vials. Ondansetron Injection Premixed in 5 percent dextrose is made by SICOR Pharmaceuticals, Inc. of Irvine, Calif. GlaxoSmithKline agreed to set aside the remainder of a six-month exclusivity agreement to make way for approval of Teva's and SICOR's generic versions.

In 2005, Zofran was the 20th most costly brand-name drug used in U.S. hospitals, according to the online publication Drug Topics.

"These approvals will result in significant savings for the American public," Gary J. Buehler, director of the FDA Office of Generic Drugs, predicted in a statement. "Generic drugs undergo a thorough scientific and regulatory review, and are safe and effective alternatives to brand-name drugs."

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