Teva gets FDA approval for generic Zofran

GlaxoSmithKline's anti-nausea drug has $750 million in US sales a year.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has obtained US Food and Drug Administration (FDA) 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 begun shipment of these products.

Teva's Ondansetron products are AB-rated generic equivalents of GlaxoSmithKline's (NYSE:GSK) Zofran, used to prevent nausea and vomiting in patients undergoing chemotherapy, radiation therapy, or surgery. Based on IMS data, ethical Zofran had $750 million in US sales in the 12 months through March 2007, and its generic equivalents have $350 million in sales over the same period.

Published by Globes [online], Israel business news - www.globes.co.il - on June 26, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

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