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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
Emergent Manufacturing Operations Baltimore LLC
5901 East Lombard Street
Baltimore, Maryland 21224
United States

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

Marketing approved:

1 Generic Name: ansuvimab-zykl
Trade Name: EBANGA™
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
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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