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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: daxibotulinumtoxinA-lanm
Trade Name: Daxxify
Date Designated: 11/16/2017
Orphan Designation: Treatment of cervical dystonia
Orphan Designation Status: Designated/Approved
Revance Therapeutics, Inc.
7555 Gateway Boulevard
Newark, California 94560
United States

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

Marketing approved:

1 Generic Name: daxibotulinumtoxinA-lanm
Trade Name: Daxxify
Marketing Approval Date: 08/11/2023
Approved Labeled Indication: treatment of cervical dystonia in adult patients
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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