Search Orphan Drug Designations and Approvals
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Generic Name: | pralsetinib | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
Genentech, Inc. 1 DNA Way South San Francisco, California 94080-4990 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | pralsetinib |
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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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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