Immunex seeking court order to require FDA review of paclitaxel ANDA.

Executive Summary

IMMUNEX GENERIC PACLITAXEL ANDA: COURT ORDER SOUGHT TO COMPEL FDA REVIEW of Immunex' application for a generic version of Bristol-Myers Squibb's anticancer agent Taxol prior to the expiration of Bristol's five-year Waxman/Hatch exclusivity on Dec. 29. In a lawsuit filed July 25 in Washington, D.C. federal court, Immunex is seeking a permanent injunction "ordering FDA to accept for review Immunex' ANDA" for paclitaxel under the Paragraph IV certification process established by the 1984 Waxman/Hatch Act. Immunex is being represented by Hyman, Phelps & McNamara (Washington, D.C.).