Search Orphan Drug Designations and Approvals
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Generic Name: | neratinib |
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Date Designated: | 08/26/2019 |
Orphan Designation: | Treatment of breast cancer patients with brain metastases |
Orphan Designation Status: | Designated/Designation Withdrawn or Revoked |
Date Designation Withdrawn or Revoked: | 04/27/2023 |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Puma Biotechnology Inc. 10880 Wilshire Blvd., Suite 2150 Los Angeles, California 90024 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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