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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: H-L-tryphophanyl-L-seryl-glycyl-L-tryptophanyl-L-seryl-L-seryl-L-cysteinyl-L-seryl-L-arginyl-L-seryl-L-cysteinyl-glycyl-OH (disulfide bond)
Date Designated: 10/20/2022
Orphan Designation: Treatment of Amyotrophic Lateral Sclerosis (ALS)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
AXOLTIS Pharma
15-17 Rue du Pré la Reine
Clermont-Ferrand 63100
France

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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