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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: repotrectinib
Trade Name: Augtyro
Date Designated: 03/12/2024
Orphan Designation: Treatment of NTRK fusion-positive solid tumors
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Company
P.O. Box 4000
Princeton, New Jersey 08543
United States

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

Marketing approved:

1 Generic Name: repotrectinib
Trade Name: Augtyro
Marketing Approval Date: 06/13/2024
Approved Labeled Indication: treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy
Exclusivity End Date: 06/13/2031 
Exclusivity Protected Indication* :  treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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