FDA — authorised 9 March 1998
- Marketing authorisation holder: BAUSCH AND LOMB
- Status: approved
🇺🇸 Lotemax in United States
FDA authorised Lotemax on 9 March 1998
Marketing authorisations
FDA — authorised 7 August 2006
- Application: NDA050804
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 22 August 2018
- Application: NDA210565
- Marketing authorisation holder: ALCON LABS INC
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 17 April 2019
- Application: ANDA207609
- Marketing authorisation holder: SENTISS
- Status: approved
FDA — authorised 13 December 2024
- Application: ANDA216345
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 10 December 2025
- Application: ANDA217597
- Marketing authorisation holder: ALEMBIC
- Status: approved
Lotemax 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 Lotemax approved in United States?
Yes. FDA authorised it on 9 March 1998; FDA authorised it on 7 August 2006; FDA authorised it on 22 August 2018.
Who is the marketing authorisation holder for Lotemax in United States?
BAUSCH AND LOMB holds the US marketing authorisation.