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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  ansuvimab-zykl
Trade Name:  EBANGA™
Date Designated:  05/08/2019
Orphan Designation:  Treatment of Ebola Virus Disease
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  12/21/2020 
Approved Labeled Indication:  EBANGA is indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection.
Exclusivity End Date:     
Exclusivity Protected Indication* :  
Ridgeback Biotherapeutics, LP
3480 Main Highway
Unit 402
Miami, Florida 33133
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.