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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: deflazacort
Trade Name: Emflaza
Date Designated: 08/16/2013
Orphan Designation: Treatment of Duchenne muscular dystrophy
Orphan Designation Status: Designated/Approved
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, New Jersey 07080
United States

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

Marketing approved:

1 Generic Name: deflazacort
Trade Name: Emflaza
Marketing Approval Date: 02/09/2017
Approved Labeled Indication: Treatment of Duchenne Muscular Dystrophy in patients 5 years of age and older
Exclusivity End Date: 02/09/2024 
Exclusivity Protected Indication* :  Treatment of Duchenne Muscular Dystrophy in patients 5 years of age and older
2 Generic Name: deflazacort
Trade Name: Emflaza
Marketing Approval Date: 06/07/2019
Approved Labeled Indication: EMFLAZA is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
Exclusivity End Date: 06/07/2026 
Exclusivity Protected Indication* :  For the treatment of Duchene muscular dystrophy in patients 2 years of age to less than 5 years 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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