AEGiS-GMHC: DRUG WATCH: FDA Committee to Consider Vestar's NDA in June Gay Men's Health CrisisImportant note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.
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DRUG WATCH: FDA Committee to Consider Vestar's NDA in June

Gay Men's Health Crisis: Treatment Issues, Volume 7 no. 5 - May, 1993
David Gold


The FDA's Oncologic Drugs Advisory Committee will review Vestar's New Drug Application (NDA) for liposomal daunorubicin (DaunoXome) as a treatment for HIV-related Kaposi's sarcoma on June 17, 1993. DaunoXome is the result of a new pharmaceutical manufacturing technique which coats drugs in fatty cells (lipids). Vestar scientists believe the fatty coat increases the ability of the drug to reach its target cells, and reduces drug toxicities. DaunoXome is available via an expanded access program to KS patients in New York, San Francisco and Los Angeles. Call 800/247-3303 for enrollment information. Some analysts predict DaunoXome will be approved by the first quarter of 1994.

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