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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name:  onasemnogene abeparvovec
Trade Name:  ZOLGENSMA
Date Designated:  09/30/2014
Orphan Designation:  Treatment of spinal muscular atrophy
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  05/24/2019 
Approved Labeled Indication:  Indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
Exclusivity End Date:    05/24/2026 
Exclusivity Protected Indication* :  Indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
AveXis, Inc.
2275 Half Day Road
Suite 200
Bannockburn, Illinois 60015
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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