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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (S)-7-(dimethylphosphoryl)-3-(2-((6,6-dimethylpiperidin-3-yl)amino)-5-(trifluoromethyl)pyrimidin-4-yl)-1H-indole-6-carbonitrile
Date Designated: 09/12/2022
Orphan Designation: Treatment of Pancreatic Cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Syros Pharmaceuticals
35 Cambridgepark Drive
Level 4
Cambridge, Massachusetts 02140
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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