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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Doxorubicin liposome
Trade Name: Doxil
Date Designated: 11/04/1998
Orphan Designation: Treatment of ovarian cancer.
Orphan Designation Status: Designated/Approved
Alza Corporation
1550 Plymouth St.
PO Box 7210
Mountain View, California 94039
United States

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

Marketing approved:

1 Generic Name: Doxorubicin liposome
Trade Name: Doxil
Marketing Approval Date: 06/28/1999
Approved Labeled Indication: Treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinium-based chemotherapy regimens. Refractory disease is defined as disease that has progressed while on treatment, or within 6 months of completing treatment.
Exclusivity End Date: 06/28/2006 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.