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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  casimersen
Trade Name:  Amondys 45
Date Designated:  06/04/2019
Orphan Designation:  Treatment of Duchenne muscular dystrophy
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  02/25/2021 
Approved Labeled Indication:  treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping
Exclusivity End Date:    02/25/2028 
Exclusivity Protected Indication* :  treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping
Sarepta Therapeutics, Inc.
215 First Street
Cambridge, Massachusetts 02142
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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