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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: risdiplam
Trade Name: Evrysdi
Date Designated: 01/04/2017
Orphan Designation: Treatment of spinal muscular atrophy
Orphan Designation Status: Designated/Approved
Genentech, Inc., a Member of the Roche Group
1 DNA Way
South San Francisco, California 94080
United States

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

Marketing approved:

1 Generic Name: risdiplam
Trade Name: Evrysdi
Marketing Approval Date: 08/07/2020
Approved Labeled Indication: treatment of spinal muscular atrophy (SMA) in patients 2 months of age and older
Exclusivity End Date: 08/07/2027 
Exclusivity Protected Indication* :  treatment of spinal muscular atrophy (SMA) in patients 2 months of age and older.
2 Generic Name: risdiplam
Trade Name: Evrysdi
Marketing Approval Date: 05/27/2022
Approved Labeled Indication: Treatment of spinal muscular atrophy (SMA) in pediatric and adult patients
Exclusivity End Date: 05/27/2029 
Exclusivity Protected Indication* :  Treatment of spinal muscular atrophy (SMA) in pediatric patients between birth and 2 months of age
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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