FDA — authorised 18 December 2017
- Marketing authorisation holder: AERIE PHARMACEUTICALS INC
- Status: approved
🇺🇸 Rhopressa in United States
FDA authorised Rhopressa on 18 December 2017
Marketing authorisations
FDA — authorised 18 December 2017
- Application: NDA208254
- Marketing authorisation holder: ALCON LABS INC
- Local brand name: RHOPRESSA
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 1 June 2020
- Application: NDA208259
- Marketing authorisation holder: ALCON LABS INC
- Indication: Labeling
- Status: approved
Rhopressa 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 Rhopressa approved in United States?
Yes. FDA authorised it on 18 December 2017; FDA authorised it on 18 December 2017; FDA authorised it on 1 June 2020.
Who is the marketing authorisation holder for Rhopressa in United States?
AERIE PHARMACEUTICALS INC holds the US marketing authorisation.