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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Bezuclastinib
Date Designated: 03/17/2023
Orphan Designation: Treatment of Mastocytosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Cogent Biosciences, Inc.
275 Wyman Street
3rd Floor
Waltham, Massachusetts 02451
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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