Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDAs 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 approximately $576 million.
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