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Ivax Generic Paclitaxel Clears FDA; Bristol Patent Case Pending In N.Y.

Executive Summary

FDA has approved Ivax' generic version of the anticancer agent paclitaxel despite Bristol-Myers Squibb's announced relisting of a recently issued patent in the "Orange Book."

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Ivax paclitaxel

First generic version of Bristol's Taxol will begin shipping within three weeks, Ivax said Sept. 20. Ivax will have 180 days of exclusivity following the launch of 30 mg/5 mL, 150 mg/25 mL and 300 mg/50 mL multiple-dose vials. Ivax made the announcement following the tentative approval of Mylan's 30 mg/5 mL paclitaxel ANDA. Ivax' ANDA was approved Sept. 15 (1"The Pink Sheet" Sept. 18, p. 3)

Ivax paclitaxel

First generic version of Bristol's Taxol will begin shipping within three weeks, Ivax said Sept. 20. Ivax will have 180 days of exclusivity following the launch of 30 mg/5 mL, 150 mg/25 mL and 300 mg/50 mL multiple-dose vials. Ivax made the announcement following the tentative approval of Mylan's 30 mg/5 mL paclitaxel ANDA. Ivax' ANDA was approved Sept. 15 (1"The Pink Sheet" Sept. 18, p. 3)

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