FDA — authorised 30 November 2018
- Application: NDA208742
- Marketing authorisation holder: OCULAR THERAPEUTIX
- Local brand name: DEXTENZA
- Indication: INSERT — OPHTHALMIC
- Status: approved
🇺🇸 Dexamethasone, 0.4mg in United States
FDA authorised Dexamethasone, 0.4mg on 30 November 2018
Marketing authorisations
FDA
- Status: approved
Dexamethasone, 0.4mg in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Dexamethasone, 0.4mg approved in United States?
Yes. FDA authorised it on 30 November 2018; FDA has authorised it.
Who is the marketing authorisation holder for Dexamethasone, 0.4mg in United States?
OCULAR THERAPEUTIX holds the US marketing authorisation.