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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: nusinersen
Trade Name: Spinraza
Date Designated: 04/18/2011
Orphan Designation: Treatment of spinal muscular atrophy
Orphan Designation Status: Designated/Approved
Biogen, Inc
225 Binney Street
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: nusinersen
Trade Name: Spinraza
Marketing Approval Date: 12/23/2016
Approved Labeled Indication: Treatment of spinal muscular atrophy in pediatric and adult patients
Exclusivity End Date: 12/23/2023 
Exclusivity Protected Indication* :  Treatment of spinal muscular atrophy in pediatric and adult patients
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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