FDA — authorised 9 February 2017
- Application: NDA208685
- Marketing authorisation holder: PTC THERAP
- Local brand name: EMFLAZA
- Indication: SUSPENSION — ORAL
- Status: approved
🇺🇸 Emflaza in United States
FDA authorised Emflaza on 9 February 2017
Marketing authorisations
FDA — authorised 9 February 2017
- Marketing authorisation holder: MARATHON PHARMACEUTICALS LLC
- Status: approved
FDA — authorised 9 February 2017
- Application: NDA208684
- Marketing authorisation holder: PTC THERAP
- Local brand name: EMFLAZA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 2024
- Application: ANDA217123
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DEFLAZACORT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 April 2024
- Application: ANDA217813
- Marketing authorisation holder: TRIS PHARMA INC
- Local brand name: DEFLAZACORT
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 November 2024
- Application: ANDA216720
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: DEFLAZACORT
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Emflaza, manufactured by Upsher Smith Labs, for its labeling indication. This approval was granted through a standard expedited pathway. Emflaza is a medication that has been authorized for marketing in the United States.
FDA — authorised 18 March 2025
- Application: ANDA217741
- Marketing authorisation holder: SUN PHARM
- Local brand name: DEFLAZACORT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 2025
- Application: ANDA219254
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: JAYTHARI
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 2025
- Application: ANDA219417
- Marketing authorisation holder: AUCTA
- Local brand name: PYQUVI
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 11 August 2025
- Application: ANDA216992
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: DEFLAZACORT
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 3 October 2025
- Application: ANDA220042
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: DEFLAZACORT
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 12 December 2025
- Application: ANDA217173
- Marketing authorisation holder: AMNEAL
- Local brand name: DEFLAZACORT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2026
- Application: ANDA219930
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: DEFLAZACORT
- Indication: SUSPENSION — ORAL
- Status: approved
The FDA approved Emflaza (deflazacort) suspension for oral use on 27 January 2026. This approval was granted to SUN PHARM INDS INC, the marketing authorisation holder. Emflaza is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 5 years and older.
Emflaza in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Emflaza approved in United States?
Yes. FDA authorised it on 9 February 2017; FDA authorised it on 9 February 2017; FDA authorised it on 9 February 2017.
Who is the marketing authorisation holder for Emflaza in United States?
PTC THERAP holds the US marketing authorisation.