Generic paclitaxel

Los Angeles federal court order requiring Bristol-Myers Squibb to de-list a Taxol formulation patent from FDA's "Orange Book" will take effect Sept. 13 unless Bristol or American BioSciences, Inc. (the owner of the patent) can obtain a stay from the federal appeals court. Removal of the patent from the "Orange Book" would eliminate the last hurdle to the approval of Ivax' generic version of the anti-cancer agent. Ivax' paclitaxel ANDA was tentatively approved by FDA Aug. 28