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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: elapegademase-lvlr
Trade Name: Revcovi
Date Designated: 03/19/2015
Orphan Designation: Treatment of adenosine deaminase deficiency in patients with severe combined immunodeficiency.
Orphan Designation Status: Designated/Approved
Chiesi USA Inc.
175 Regency Woods Place
Suite 600
Cary, North Carolina 27518
United States

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

Marketing approved:

1 Generic Name: elapegademase-lvlr
Trade Name: Revcovi
Marketing Approval Date: 10/05/2018
Approved Labeled Indication: Treatment of Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID).
Exclusivity End Date: 10/05/2025 
Exclusivity Protected Indication* :  treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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