Teva announces tentative FDA approval of Ondansetron Injection USP

By Ted A. Knutson

Washington, Feb. 27 - Teva Pharmaceutical Industries Ltd. announced Monday the Food and Drug Administration has granted tentative approval for Ondansetron Injection USP, 2 mg/mL, packaged in 4 mg/2 mL single-dose vials and Ondansetron Injection USP, 2 mg/mL, packaged in 40 mg/20 mL multiple-dose vials.

Upon final approval, Teva's Ondansetron Injection products will be the AP-rated generic equivalent of GlaxoSmithKline's Zofran Injection.

The product is indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin, and prevention of postoperative nausea and/or vomiting.

Total annual U.S. sales of the brand product, in both configurations, are about $576 million.

Teva is a Jerusalem, Israel-based biotechnology company.

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