Bristol Taxol approved for Kaposi's sarcoma, setting up orphan drug conflict with Ivax.

Executive Summary

BRISTOL TAXOL KAPOSI's INDICATION APPROVED BUT LABELING NOT FINAL: the orphan-designated use for Bristol-Myers Squibb's Taxol (paclitaxel) as a second-line agent for treatment of AIDS-related Kaposi's sarcoma cleared FDA Aug. 4, but labeling has yet to be finalized, the agency said. The directions for use of Taxol are an important element in light of a looming orphan drug dispute with Ivax over paclitaxel use for KS. Ivax' hopes for approval of its Paxene brand of paclitaxel hinge on its ability to show a difference between the products in KS under the orphan drug regulations.