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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 2-[(3S)-2,6-dioxopiperidin-3-yl]-4-{[(2-fluoro-4-{[3-(morpholin-4-yl)azetidin-1-yl]methyl} phenyl) methyl]amino}-1H-isoindole-1,3(2H)-dione-hydrogen chloride (1/1)
Date Designated: 01/25/2023
Orphan Designation: Treatment of Follicular Lymphoma (FL)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Celgene Coporation
86 Morris Avenue
Summit, New Jersey 07901
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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