Deflazacort

Treats Duchenne muscular dystrophy (DMD). Sold as Emflaza. Every FDA application for this active ingredient: 2 branded and 13 generic.

As of Nov 14, 2026, FDA lists 15 applications for Deflazacort (sold as Emflaza), first approved Feb 9, 2017, with 2 new uses approved and 0 published complete response letters.

First approved: Feb 9, 2017
Applications: 15
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $18.0M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Emflaza	Part D	$14.3M	-7%	94
Deflazacort	Part D	$3.7M	+186%	56

Orphan Designations (FDA)

4 designations, 2 approved for the designated use; see all orphan designations

Treatment of pediatric (0 through 16 years of age) juvenile idiopathis arthritis (JIA) International League of…PTC Therapeutics, Inc. · designated Oct 22, 2015 · withdrawn
Treatment of Duchenne muscular dystrophyPTC Therapeutics, Inc. · designated Aug 16, 2013 · approved Feb 9, 2017
Treatment of Duchenne muscular dystrophyPTC Therapeutics, Inc. · designated Aug 16, 2013 · approved Jun 7, 2019
Treatment of Duchenne muscular dystrophyUniversity of Rochester Medical Center · designated Sep 16, 2010

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Deflazacort Vs. Prednisolone in Acute-stage ABPAAllergic Bronchopulmonary Aspergillosis · Post Graduate Institute of Medical Education and Research, Chandigarh	Phase 2 / Phase 3	Active, not recruiting	Jan 13, 2020

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Feb 9, 2017	EmflazaNDA 208684 · New molecular entity	Ptc Therap	4	Marketed
Feb 9, 2017	EmflazaNDA 208685 · New molecular entity	Ptc Therap	4	Marketed
Feb 9, 2024	DeflazacortANDA 217123	Aurobindo Pharma Ltd	1	Marketed
Apr 25, 2024	DeflazacortANDA 217813	Tris Pharma Inc	1	Marketed
Nov 5, 2024	DeflazacortANDA 216720	Upsher Smith Labs	1	Marketed
Mar 18, 2025	DeflazacortANDA 217741	Sun Pharm	0	Marketed
Apr 8, 2025	JaythariANDA 219254	Zydus Lifesciences	0	Marketed
Jun 30, 2025	PyquviANDA 219417	Aucta	0	Marketed
Aug 11, 2025	DeflazacortANDA 216992	Upsher Smith Labs	1	Marketed
Oct 3, 2025	DeflazacortANDA 220042	Zydus Lifesciences	1	Marketed
Dec 12, 2025	DeflazacortANDA 217173	Amneal	0	Marketed
Jan 27, 2026	DeflazacortANDA 219930	Sun Pharm Inds Inc	0	Marketed
May 28, 2026	DeflazacortANDA 220709	Biocon Pharma	0	Marketed
Sep 18, 2026	DeflazacortANDA 220524	Hikma	0	Marketed
Oct 19, 2026	DeflazacortANDA 217103	Teva Pharms Inc	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA