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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:  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:    12/21/2027 
Exclusivity Protected Indication* :  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
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.
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