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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
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.
Genentech, Inc., a Member of the Roche Group
1 DNA Way
South San Francisco, California 94080-4990
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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