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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Edralbrutinib
Date Designated: 04/24/2023
Orphan Designation: Treatment of neuromyelitis optica spectrum disorder
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Reistone Biopharma Company Limited
No. 298 Xiangke Road, Youyue Plus, 2nd Floor, #203, Pudong
Shanghai, Shanghai 21210

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.