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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: anacaulase-bcdb
Trade Name: NexoBrid
Date Designated: 08/20/2003
Orphan Designation: Debridement of acute, deep dermal burns in hospitalized patients
Orphan Designation Status: Designated/Approved
MediWound, Ltd.
42 Hayarkon Street
Yavne
Israel

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

Marketing approved:

1 Generic Name: anacaulase-bcdb
Trade Name: NexoBrid
Marketing Approval Date: 12/28/2022
Approved Labeled Indication: eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns
Exclusivity End Date: 12/28/2029 
Exclusivity Protected Indication* :  eschar removal in hospitalized adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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