FDA — authorised 11 February 1986
- Marketing authorisation holder: ALCON
- Status: approved
🇺🇸 Flarex in United States
FDA authorised Flarex on 11 February 1986
Marketing authorisations
FDA — authorised 11 February 1986
- Application: NDA019079
- Marketing authorisation holder: HARROW EYE
- Local brand name: FLAREX
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 21 July 1989
- Application: NDA050628
- Marketing authorisation holder: HARROW EYE
- Local brand name: TOBRASONE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
Flarex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Flarex approved in United States?
Yes. FDA authorised it on 11 February 1986; FDA authorised it on 11 February 1986; FDA authorised it on 21 July 1989.
Who is the marketing authorisation holder for Flarex in United States?
ALCON holds the US marketing authorisation.