Kaposi's Sarcoma

FDA Advisory Panel to Review Paxene Announced

Published in AIDS Weekly, August 18th, 1997

Ivax Corp., Miami, Florida, announced that it has been invited to present clinical data regarding Paxene for Kaposi's sarcoma (KS) to the U.S. Food and Drug Administration's (FDA) Oncology Drugs Advisory Committee (ODAC) on September 19, 1997.

Earlier in 1997, Ivax and NaPro BioTherapeutics, Inc. submitted a New Drug Application to the FDA seeking approval to manufacture and market Paxene in the United States for the treatment of KS, an important cancer related to the immunocompromised state that accompanies AIDS. Ivax has applied for exclusivity under the Orphan Drug Act. Paxene is Ivax's registered trade name for the compound paclitaxel (also called taxol).

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Source: AIDS Weekly (1997-08-18)

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