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Teva gets U.S. FDA approval of ANDA for ondansetron injection used to treat nausea, vomiting

Published in FDA Law Weekly, December 28th, 2006

Teva Pharmaceutical Industries Ltd. (TEVA) announced that the U.S. Food and Drug Administration has granted final approval for the company's abbreviated new drug applications (ANDAs) for ondansetron injection USP, 2 mg/mL, packaged in 4 mg/2 mL single-dose vials, 2 mg/mL, packaged in 40 mg/20 mL multiple-dose vials and 0.64 mg/mL packaged in 32 mg/50 mL bags.

Shipment of these products will begin immediately following a 2005 patent litigation settlement with GlaxoSmithKline.

Teva's ondansetron injection products are the AP-rated generic equivalent of GlaxoSmithKline's antiemetic Zofran injection.

The product, in the three...

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