The US Food and Drug Administration has granted tentative approval for the Teva Pharmaceuticals' 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 vomiting, states a Teva release.
Total annual US sales of the brand product, in both configurations, are approximately $576 million.
Teva Pharmaceutical Industries Ltd. is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products.