FDA — authorised 18 May 2023
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Status: approved
🇺🇸 Miebo in United States
FDA authorised Miebo on 18 May 2023
Marketing authorisations
FDA — authorised 18 May 2023
- Application: NDA216675
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Indication: Type 1 - New Molecular Entity
- Status: approved
Miebo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Ophthalmology approved in United States
Frequently asked questions
Is Miebo approved in United States?
Yes. FDA authorised it on 18 May 2023; FDA authorised it on 18 May 2023.
Who is the marketing authorisation holder for Miebo in United States?
BAUSCH AND LOMB INC holds the US marketing authorisation.