Search Orphan Drug Designations and Approvals
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Generic Name: | CDK inhibitor (CDKI) of CDK2/4/6 |
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Date Designated: | 03/03/2021 |
Orphan Designation: | Treatment of patients with malignant gliomas (including glioblastoma, astrocytoma, and oligodendroglioma) |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
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. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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