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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: N-[(2R)-2,3 dihydroxypropoxyl]-3,4 difluro-2 -[(2-fluoro-4-iodophenyl)amino] benzamide
Date Designated: 10/30/2018
Orphan Designation: Treatment of Neurofibromatosis type I
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
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.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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