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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mirdametinib
Trade Name: Gomekli
Date Designated: 10/30/2018
Orphan Designation: Treatment of Neurofibromatosis type I
Orphan Designation Status: Designated/Approved
SpringWorks Therapeutics, Inc.
575 5th Avenue, 16th Floor
New York, New York 10017
United States

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

Marketing approved:

1 Generic Name: mirdametinib
Trade Name: Gomekli
Marketing Approval Date: 02/11/2025
Approved Labeled Indication: treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection
Exclusivity End Date: 02/11/2032 
Exclusivity Protected Indication* :  treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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