Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: repotrectinib
Trade Name: Augtyro
Date Designated: 06/22/2017
Orphan Designation: Treatment of non-small cell lung cancer with adenocarcinoma histology
Orphan Designation Status: Designated/Approved
Bristol Myers Squibb Company
3401 Princeton Pike
Lawrenceville , New Jersey 08648
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: 11/15/2023
Approved Labeled Indication: treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)
Exclusivity End Date: 11/15/2030 
Exclusivity Protected Indication* :  treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) with adenocarcinoma histology
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-