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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: rezafungin
Trade Name: Rezzayo
Date Designated: 02/08/2016
Orphan Designation: Treatment of candidemia and invasive candidiasis infections caused by susceptible Candida spp.
Orphan Designation Status: Designated/Approved
Mundipharma GmbH
De-Saint-Exupery-Str. 10
Frankfurt am Main 60549
Germany

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

Marketing approved:

1 Generic Name: rezafungin
Trade Name: Rezzayo
Marketing Approval Date: 03/22/2023
Approved Labeled Indication: in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis
Exclusivity End Date: 03/22/2030 
Exclusivity Protected Indication* :  in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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