Quick answers
- What is Deflazacort used for?
- The FDA-approved label (Jaythari, Doppel Farmaceutici S.r.l., August 27, 2026) says: “JAYTHARI is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. JAYTHARI is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Deflazacort have a boxed warning?
- No. None of the 16 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Deflazacort?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Deflazacort been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Deflazacort?
- 12 companies list prescription products of Deflazacort in the FDA NDC Directory, including Zydus Pharmaceuticals USA Inc., Doppel Farmaceutici S.r.l. and Upsher-Smith Laboratories, LLC.
What Deflazacort is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
JAYTHARI is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. JAYTHARI is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older
— FDA label: Jaythari, Doppel Farmaceutici S.r.l., effective August 27, 2026. Read the full label on DailyMed →
The FDA has 16 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Suspension |
|---|---|
| Route | Oral |
| Prescription products | 58 in the FDA NDC Directory |
| Brand names | Jaythari, Emflaza, Kymbee, Jaythari Oral Suspension, Pyquvi |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Zydus Pharmaceuticals USA Inc.10 products
- Doppel Farmaceutici S.r.l.10 products
- Upsher-Smith Laboratories, LLC9 products
- PTC Therapeutics, Inc.5 products
- Sun Pharmaceutical Industries, Inc.5 products
- Amneal Pharmaceuticals NY LLC4 products
- Aurobindo Pharma Limited4 products
- Hikma Pharmaceuticals USA Inc.4 products
- AvKARE4 products
- Aucta Pharmaceuticals, Inc.1 product
- Biocon Pharma Inc.1 product
- Cranbury Pharmaceuticals, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208684 EMFLAZA | Ptc Therap | February 9, 2017 | 4, latest June 5, 2024 2024: Labeling · 2021: Labeling · 2020: Labeling |
| NDA208685 EMFLAZA | Ptc Therap | February 9, 2017 | 4, latest June 5, 2024 2024: Labeling · 2021: Labeling · 2020: Labeling |
Generic approvals (12)
- ANDA217123Aurobindo Pharma Ltd · February 9, 2024
- ANDA217813Tris Pharma Inc · April 25, 2024
- ANDA216720Upsher Smith Labs · November 5, 2024
- ANDA217741Sun Pharm · March 18, 2025
- ANDA219254Zydus Lifesciences · April 8, 2025
- ANDA219417Aucta · June 30, 2025
- ANDA216992Upsher Smith Labs · August 11, 2025
- ANDA220042Zydus Lifesciences · October 3, 2025
- ANDA217173Amneal · December 12, 2025
- ANDA219930Sun Pharm Inds Inc · January 27, 2026
- ANDA220709Biocon Pharma · May 28, 2026
- ANDA220524Hikma · September 18, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Jaythari, Doppel Farmaceutici S.r.l., effective August 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →