Court Says FDA Should Not Have Approved Generic Version of Taxol

A U.S. appeals court ruled on Tuesday that the Food and Drug Administration had no right to approve the marketing of Ivax Corp.'s generic version of Bristol-Myers Squibb Co.'s top-selling cancer drug Taxol.

The appeals court ordered that the FDA's approval be vacated. However, given that the lower-cost generic has been on the market for about a year, the court said it was unsure what can now be done to control marketing of generic versions of Taxol.

``We frankly do not know what recourse is left to the FDA or other government agencies to take any steps that would affect the marketing of generic versions of Taxol,'' the court said in its opinion.

Ivax said it would seek reconsideration of the ''incorrect'' decision and said it did not believe the ruling would prevent it from continuing to sell its copycat Taxol.

Other Sources: U.S. Court of Appeals