FDA — authorised 11 July 2016
- Application: NDA208073
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Status: supplemented
🇺🇸 Xiidra in United States
FDA authorised Xiidra on 11 July 2016
Marketing authorisations
FDA
- Status: approved
FDA
- Application: ANDA215126
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: LIFITEGRAST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Xiidra approved in United States?
Yes. FDA authorised it on 11 July 2016; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Xiidra in United States?
BAUSCH AND LOMB INC holds the US marketing authorisation.