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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
Date Designated:  08/25/2009
Orphan Designation:  Treatment of hepatocellular carcinoma.
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Delcath Systems, Inc.
1301 6th Avenue
43rd Floor
New York, New York 10019
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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