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Molecule

Deflazacort

Corticosteroid
Available on requestOrphanEndocrinology
Presentations
21
Brands
5
Manufacturers
4
Available from stock
0

Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. It is available as tablets and oral suspension. MedsAcross supplies Deflazacort for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Corticosteroid, Corticosteroid Hormone Receptor Agonists
ATC classification
H02AB13 Deflazacort · Glucocorticoid
US FDA first approval
9 February 2017
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet, Oral suspension
Identifiers
UNII KR5YZ6AE4BRxCUI 22396CAS 14484-47-0DrugBank DB11921Q779118

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

EMFLAZA is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. EMFLAZA is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older

Source: US FDA prescribing information

How it works

Deflazacort is a corticosteroid prodrug, whose active metabolite, 21-desDFZ, acts through the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects. The precise mechanism by which deflazacort exerts its therapeutic effects in patients with DMD is unknown.

Source: US FDA prescribing information

Dosing overview

The recommended once-daily dosage is approximately 0.9 mg/kg/day administered orally. Discontinue gradually when administered for more than a few days

Source: US FDA prescribing information

Contraindications

EMFLAZA is contraindicated in patients with known hypersensitivity to deflazacort or to any of the inactive ingredients. Instances of hypersensitivity, including anaphylaxis, have occurred in patients receiving corticosteroid therapy. Hypersensitivity to deflazacort or any of the inactive ingredients in EMFLAZA

Source: US FDA prescribing information

Warnings and precautions

Alterations in Endocrine Function: Hypothalamic-pituitary-adrenal axis suppression, Cushing’s syndrome, and hyperglycemia can occur, Monitor patients for these conditions with chronic use of EMFLAZA. Immunosuppression and Increased Risk of Infection: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections, which can be severe and at times fatal, Signs and symptoms of infection may be masked. Alterations in Cardiovascular/Renal Function: Monitor for elevated blood pressure and sodium, and for decreased potassium levels. Gastrointestinal Perforation: Increased risk in patients with certain GI disorders, Signs and symptoms may be masked. Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are discussed in more detail in other sections: Alterations in Endocrine Function Immunosuppression and Increased Risk of Infection Alterations in Cardiovascular/Renal Function Gastrointestinal Perforation Behavioral and Mood Disturbances Effects on Bones Ophthalmic Effects Immunizations Serious Skin Rashes Effects on Growth and Development Myopathy Kaposi’s Sarcoma Risk of Serious Adverse Reactions in Infants because of Benzyl Alcohol Preservative Thromboembolic Events Anaphylaxis The most common adverse reactions (≥ 10% for EMFLAZA and greater than placebo) are Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis

Source: US FDA prescribing information

Interactions

Moderate or strong CYP3A4 inhibitors: Give one third of the recommended dosage of EMFLAZA. Avoid use of moderate or strong CYP3A4 inducers with EMFLAZA, as they may reduce efficacy

Source: US FDA prescribing information

Storage

Store at 20°C to 25°C (68°F to 77°F). Excursion permitted between 15°C to 30°C (59°F to 86°F). See USP controlled room temperature.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

21 presentations of Deflazacort, sorted by availability.

MedicineManufacturerRegisterAvailability
Deflazacort 18 mg tabletOralGeneric name—US FDAAvailable on request
Deflazacort 30 mg tabletOralGeneric name—US FDAAvailable on request
Deflazacort 36 mg tabletOralGeneric name—US FDAAvailable on request
Deflazacort 6 mg tabletOralGeneric name—US FDAAvailable on request
Deflazacort 22.75 mg/mL oral suspensionOralGeneric name—US FDAAvailable on request
Jaythari 18 mg tabletOralZydus LifesciencesIndiaUS FDAAvailable on request
Jaythari 30 mg tabletOralZydus LifesciencesIndiaUS FDAAvailable on request
Jaythari 36 mg tabletOralZydus LifesciencesIndiaUS FDAAvailable on request
Jaythari 6 mg tabletOralZydus LifesciencesIndiaUS FDAAvailable on request
Emflaza 18 mg tabletOralPTC TherapeuticsUS FDAAvailable on request
Emflaza 22.75 mg/mL oral suspensionOralPTC TherapeuticsUS FDAAvailable on request
Emflaza 30 mg tabletOralPTC TherapeuticsUS FDAAvailable on request
Emflaza 36 mg tabletOralPTC TherapeuticsUS FDAAvailable on request
Emflaza 6 mg tabletOralPTC TherapeuticsUS FDAAvailable on request
JAYTHARI Oral Suspension 22.75 mg/mL oral suspensionOralZydus LifesciencesIndiaUS FDAAvailable on request
Kymbee 18 mg tabletOralUpsher-Smith LaboratoriesUS FDAAvailable on request
Kymbee 22.75 mg/mL oral suspensionOralUpsher-Smith LaboratoriesUS FDAAvailable on request
Kymbee 30 mg tabletOralUpsher-Smith LaboratoriesUS FDAAvailable on request
Kymbee 36 mg tabletOralUpsher-Smith LaboratoriesUS FDAAvailable on request
Kymbee 6 mg tabletOralUpsher-Smith LaboratoriesUS FDAAvailable on request
Pyquvi 22.75 mg/mL oral suspensionOralAucta PharmaceuticalsUS FDAAvailable on request

Brands by market

5 brand names across 1 markets.

Brand names by country

Manufacturers

Indian manufacturers are highlighted.

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 9 February 2017Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Deflazacort in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Deflazacort available for export from India?

Yes, on request. MedsAcross lists 21 presentations of Deflazacort and sources them for licensed hospitals, importers and physicians against valid import documents. Indian manufacturers include Zydus Lifesciences.

What brand names does Deflazacort have?

The catalogue lists 5 brand names for Deflazacort, including Emflaza, Jaythari, JAYTHARI Oral Suspension, Kymbee, Pyquvi.

Is Deflazacort approved by the US FDA?

Yes. The US FDA first approved Deflazacort on 9 February 2017, according to Drugs@FDA.

Does Deflazacort need cold chain shipping?

No listed presentation of Deflazacort is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Deflazacort in?

Deflazacort is classified under ATC code H02AB13 (Deflazacort).

References

  1. EMFLAZA prescribing information (PTC Therapeutics). U.S. National Library of Medicine, DailyMed. Retrieved 13 October 2026

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