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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: givinostat
Trade Name: Duvyzat
Date Designated: 04/12/2013
Orphan Designation: Treatment of Duchenne Muscular Dystrophy and Becker Muscular Dystrophy
Orphan Designation Status: Designated/Approved
Italfarmaco SpA
Via dei Lavoratori, 54
20092 Cinisello Balsamo
Italy

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

Marketing approved:

1 Generic Name: givinostat
Trade Name: Duvyzat
Marketing Approval Date: 03/21/2024
Approved Labeled Indication: treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older
Exclusivity End Date: 03/21/2031 
Exclusivity Protected Indication* :  treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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