Approval of Ivax’s Version of Taxol Challenged

Ivax Corp. faces a revived legal challenge to its generic version of the top-selling Taxol cancer drug, after a federal appeals court told a trial judge to reexamine the Food and Drug Administration’s approval of the Ivax product. The ruling is the latest in a multifaceted legal fight involving Ivax, Taxol manufacturer Bristol-Myers Squibb Co. and American BioScience Inc., which says it has a patented method to reduce the drug’s side effects. The U.S. Court of Appeals for the D.C. Circuit said U.S. District Judge Colleen Kollar-Kotelly lacked adequate information when she rejected American BioScience’s claim that the FDA shouldn’t have approved the Ivax drug. The appeals court faulted her for not reviewing the full record of the FDA’s proceedings. Miami-based Ivax fell 9 cents to close at $31.50 on the American Stock Exchange, while Bristol-Myers fell 17 cents to close at $59.40 on the Big Board.