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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tofersen
Trade Name: Qalsody
Date Designated: 09/19/2016
Orphan Designation: Treatment of amyotrophic lateral sclerosis
Orphan Designation Status: Designated/Approved
Biogen Inc.
225 Binney St.
Cambridge, Massachusetts 02142
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: tofersen
Trade Name: Qalsody
Marketing Approval Date: 04/25/2023
Approved Labeled Indication: treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene
Exclusivity End Date: 04/25/2030 
Exclusivity Protected Indication* :  treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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