Teva Pharmaceutical Industries Ltd. announced that the US Food and Drug Administration has granted approval for the company's Abbreviated New Drug Applications (ANDA) to market Ondansetron Hydrochloride tablets, 4 mg, 8 mg and 24 mg and Ondansetron Orally Disintegrating tablets USP, 4 mg and 8 mg. Teva has commenced shipment of these products.
Teva's Ondansetron products are AB-rated generic equivalents of GlaxoSmithKline's Zofran tablets and Zofran ODT, which are indicated for prevention of nausea and vomiting in patients undergoing chemotherapy, radiation therapy, or surgery.
Total annual sales of Ondansetron HCl Tablets and Ondansetron Orally Disintegrating tablets, including brand and generic sales, are approximately $750 million and $350 million, respectively, in the U.S. for the twelve months ended March 2007, based on IMS data.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, 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. Over 76 percent of Teva's sales are in North America and Europe.