Search Orphan Drug Designations and Approvals
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Generic Name: | an orally bioavailable ALK inhibitor (a macrocyclic compound containing nitrogen heterocycles) |
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Date Designated: | 03/20/2023 |
Orphan Designation: | Treatment of ALK-positive, ROS1-positive, and LTK-positive non-small cell lung cancer (NSCLC) |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Nuvalent, Inc. One Broadway 14th Floor Cambridge, Massachusetts 02142 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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