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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Inhibitor of neurotrophic tyrosine receptor kinase (NTRK)
Date Designated: 06/15/2022
Orphan Designation: Treatment of neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumors
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 07/25/2024
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Pyramid Biosciences
330 Bear Hill Road
Suite 302
Waltham, Massachusetts 02451
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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