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  1. Search Orphan Drug Designations and Approvals - accessdata.fda.gov

    May 14, 1993 · First line cytotoxic therapy for advanced, HIV related Kaposi's sarcoma. *Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present. …

    Missing:
    • DaunoXome
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  2. Daunorubicin liposomal (DaunoXome) - HemOnc.org

    1996-04-08: Initial FDA approval as a first-line cytotoxic therapy for the treatment of advanced, HIV-associated Kaposi's sarcoma (KS). (Based on Gill et al. 1996)

  3. Liposomal daunorubicin - Wikipedia

    Liposomal daunorubicin (trade name DaunoXome) is a chemotherapy drug that is FDA approved to treat AIDS related Kaposi's sarcoma. It is also commonly used to treat specific types of …

  4. NeXstar's DaunoXome Sees US Launch - Pharmaceutical industry …

    May 12, 1996 · The product was approved by the US Food and Drug Administration on April 8, following the agency's review of NeXstar's Phase III clinical trial comparing single-agent …

  5. FDA Approval History - Drugs.com

    Nov 13, 2025 · This list consists of medications tracked by Drugs.com through the application and approval process at the U.S. Food and Drug Administration (FDA). Where possible, we have …

    Missing:
    • DaunoXome
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  6. DAUNOXOME (DAUNORUBICIN CITRATE) - 美国FDA药品数据库

    药品名称:DAUNOXOME,活性成分:DAUNORUBICIN CITRATE,剂型:INJECTABLE, LIPOSOMAL;INJECTION,规格:EQ 2MG BASE/ML,药品注册申请号:050704,产品号:002

  7. ODAC Recommends Ethyol, DaunoXome For FDA Approval

    Jun 16, 1995 · “Unfortunate Result Of Burzynski’s Practice Over Two Decades: Thousands Of Patients, Not Enough Data” To Determine Safety, Efficacy, FDA Says September 25, 1998

  8. Pharmaceutical drug prices and trends for DaunoXome FDA first approval year

    Branded and Generic pharmaceutical prices for DaunoXome FDA first approval year

  9. Please refer to your supplemental new drug application dated May 14, 1999, received May 17, 1999, and submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for …

  10. Federal Register, Volume 62 Issue 55 (Friday, March 21, 1997)

    Mar 21, 1997 · In letters dated December 2, 1996, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval …