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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Allogenic spinal motor neuron precursor cell
Date Designated: 11/22/2023
Orphan Designation: Treatment of amyotrophic lateral sclerosis (ALS)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd
99 Jingu Road (Phase 3, Zone B), Building 3, Unit 201
Suzhou Industrial Park District
Suzhou, Jiangsu 215000
China

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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