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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: pralsetinib
Trade Name: GAVRETO™
Date Designated: 04/11/2018
Orphan Designation: Treatment of rearranged during transfection (RET)-rearranged non-small cell lung cancer (NSCLC), JAK1/2-positive NSCLC, or TRKC-positive NSCLC.
Orphan Designation Status: Designated/Approved
Rigel Pharmaceuticals, Inc.
611 Gateway Blvd Suite 900
South San Francisco, California 94080
United States

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

Marketing approved:

1 Generic Name: pralsetinib
Trade Name: GAVRETO™
Marketing Approval Date: 09/04/2020
Approved Labeled Indication: treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
Exclusivity End Date: 09/04/2027 
Exclusivity Protected Indication* :  treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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