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Mylan paclitaxel

Executive Summary

Second generic version of Bristol-Myers Squibb's Taxol (paclitaxel) enters market following FDA's July 23 approval of Mylan's ANDA. The approval covers 30 mg/5 mL, 100 mg/16.7 mL and 300 mg/50 mL vials. Mylan's approval was delayed beyond the expiration of Ivax' 180-day generic exclusivity April 22, due to amendments pending at FDA to include the 100 mg and 300 mg vials (which were not in the original application), and to approve a second paclitaxel raw material source, Mylan said. The company expects the second source in China to allow it to expand its capacity from 35 kg of raw material to 64 kg

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