Regulatory PathRegulatory requirements compared

Active substance

Deflazacort

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Disflax30 mgTablet · Oral use10 BlisterSAR 28.50Generic · PrescriptionFAES FARMA, S.A.Valid
Disflax6 mgTablet · Oral use20 BlisterSAR 11.40Generic · PrescriptionFAES FARMA, S.A.Valid

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
EMFLAZA6MG; 18MG; 30MG; 36MGtablet · oralPTC THERAPPrescription9 Feb 2017
EMFLAZA22.75MG/MLsuspension · oralPTC THERAPPrescription9 Feb 2017
DEFLAZACORT6MG; 18MG; 30MG; 36MGtablet · oralAUROBINDO PHARMA LTDPrescription9 Feb 2024
DEFLAZACORT22.75MG/MLsuspension · oralTRIS PHARMA INCPrescription25 Apr 2024
DEFLAZACORT6MG; 18MG; 30MG; 36MGtablet · oralUPSHER SMITH LABSPrescription5 Nov 2024
DEFLAZACORT6MG; 18MG; 30MG; 36MGtablet · oralSUN PHARMPrescription18 Mar 2025
JAYTHARI6MG; 18MG; 30MG; 36MGtablet · oralZYDUS LIFESCIENCESPrescription8 Apr 2025
PYQUVI22.75MG/MLsuspension · oralAUCTAPrescription30 Jun 2025
DEFLAZACORT22.75MG/MLsuspension · oralUPSHER SMITH LABSPrescription11 Aug 2025
DEFLAZACORT22.75MG/MLsuspension · oralZYDUS LIFESCIENCESPrescription3 Oct 2025
DEFLAZACORT6MG; 18MG; 30MG; 36MGtablet · oralAMNEALPrescription12 Dec 2025
DEFLAZACORT22.75MG/MLsuspension · oralSUN PHARM INDS INCPrescription27 Jan 2026
DEFLAZACORT22.75MG/MLsuspension · oralBIOCON PHARMAPrescription28 May 2026
DEFLAZACORT6MG; 18MG; 30MG; 36MGtablet · oralHIKMA PHARMSPrescription18 Sep 2026

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffDeflazacort 6mg tablets£15.8260 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

  • US FDA 5 Jun 2024 EMFLAZA — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 5 Jun 2024 EMFLAZA — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for deflazacort →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.