FDA — authorised 11 July 2016
- Marketing authorisation holder: SHIRE DEV LLC
- Status: approved
🇺🇸 Xiidra in United States
FDA authorised Xiidra on 11 July 2016
Marketing authorisations
FDA — authorised 17 December 2017
- Application: NDA208073
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Indication: Labeling
- Status: approved
FDA — authorised 7 November 2023
- Application: ANDA215063
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA
- Application: ANDA215126
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: LIFITEGRAST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
Xiidra 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 Xiidra approved in United States?
Yes. FDA authorised it on 11 July 2016; FDA authorised it on 17 December 2017; FDA authorised it on 7 November 2023.
Who is the marketing authorisation holder for Xiidra in United States?
SHIRE DEV LLC holds the US marketing authorisation.