FDA — authorised 2 November 2017
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Status: approved
🇺🇸 Vyzulta in United States
FDA authorised Vyzulta on 2 November 2017
Marketing authorisations
FDA — authorised 2 November 2017
- Application: NDA207795
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: VYZULTA
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 29 April 2025
- Application: ANDA217387
- Marketing authorisation holder: GLAND
- Local brand name: LATANOPROSTENE BUNOD
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
Vyzulta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Vyzulta approved in United States?
Yes. FDA authorised it on 2 November 2017; FDA authorised it on 2 November 2017; FDA authorised it on 29 April 2025.
Who is the marketing authorisation holder for Vyzulta in United States?
BAUSCH AND LOMB INC holds the US marketing authorisation.