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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: taletrectinib
Trade Name: Ibtrozi
Date Designated: 07/16/2024
Orphan Designation: treatment of ROS1-positive, NTRK positive, ALK-positive, LTK-positive, ACK1-positive, or DDR1-positive non-small cell lung cancer (NSCLC)
Orphan Designation Status: Designated/Approved
Nuvation Bio Inc.
1500 Broadway, Suite 1401
New York, New York 10036
United States

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

Marketing approved:

1 Generic Name: taletrectinib
Trade Name: Ibtrozi
Marketing Approval Date: 06/11/2025
Approved Labeled Indication: treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)
Exclusivity End Date: 06/11/2032 
Exclusivity Protected Indication* :  treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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