FDA — authorised 2 March 2020
- Application: NDA208742
- Marketing authorisation holder: OCULAR THERAPEUTIX
- Indication: Labeling
- Status: approved
🇺🇸 Decadron in United States
FDA authorised Decadron on 2 March 2020
Marketing authorisations
FDA — authorised 16 August 2022
- Application: NDA050818
- Marketing authorisation holder: HARROW EYE
- Indication: Labeling
- Status: approved
FDA — authorised 8 September 2022
- Application: ANDA216295
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 26 April 2023
- Application: ANDA217538
- Marketing authorisation holder: BIONPHARMA
- Status: approved
FDA — authorised 5 June 2024
- Application: ANDA084282
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
The FDA approved Decadron for labeling indications. This approval was granted to HIKMA on 2024-06-05. Decadron was approved through the standard expedited pathway.
Decadron in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Decadron approved in United States?
Yes. FDA authorised it on 2 March 2020; FDA authorised it on 16 August 2022; FDA authorised it on 8 September 2022.
Who is the marketing authorisation holder for Decadron in United States?
OCULAR THERAPEUTIX holds the US marketing authorisation.