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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Daunorubicin citrate liposome injection
Trade Name: DaunoXome
Date Designated: 05/14/1993
Orphan Designation: Treatment of patients with advanced HIV-associated Kaposi's sarcoma.
Orphan Designation Status: Designated/Approved
NeXstar Pharmaceuticals, Inc.
650 Cliffside Drive
San Dimas, California 91773
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Daunorubicin citrate liposome injection
Trade Name: DaunoXome
Marketing Approval Date: 04/08/1996
Approved Labeled Indication: First line cytotoxic therapy for advanced, HIV related Kaposi's sarcoma.
Exclusivity End Date: 04/08/2003 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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