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In Brief: Abbott paclitaxel

Executive Summary

Abbott paclitaxel: ANDAs for paclitaxel injection concentrate 6 mg/mL, 100 mg/16.7 mL, 200 mg/33.3 mL, and 300 mg/50 mL single-dose vials referencing Bristol-Myers Squibb's Taxol may be submitted, FDA determines in an April 29 response to Abbott's ANDA suitability petition filed in November. FDA reminds Abbott that it may not submit an ANDA for paclitaxel until expiration of marketing exclusivity for Taxol, which is Dec. 29, 1997...
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