FDA — authorised 9 March 1998
- Application: NDA020583
- Marketing authorisation holder: BAUSCH AND LOMB
- Status: supplemented
🇺🇸 Lotemax in United States
FDA authorised Lotemax on 9 March 1998 · 2,836 US adverse-event reports
Marketing authorisations
FDA — authorised 9 March 1998
- Application: NDA020841
- Marketing authorisation holder: PHARMOS
- Local brand name: LOTEMAX
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 15 April 2011
- Application: NDA200738
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: LOTEMAX
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 28 September 2012
- Application: NDA202872
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Local brand name: LOTEMAX
- Indication: GEL — OPHTHALMIC
- Status: approved
FDA — authorised 22 February 2019
- Application: NDA208219
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 2,836
Most-reported reactions
- Eye Pain — 484 reports (17.07%)
- Eye Irritation — 428 reports (15.09%)
- Off Label Use — 349 reports (12.31%)
- Vision Blurred — 335 reports (11.81%)
- Drug Ineffective — 290 reports (10.23%)
- Ocular Hyperaemia — 252 reports (8.89%)
- Headache — 198 reports (6.98%)
- Fatigue — 177 reports (6.24%)
- Dry Eye — 165 reports (5.82%)
- Nausea — 158 reports (5.57%)
Lotemax in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other 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 9 March 1998; FDA authorised it on 15 April 2011.
Who is the marketing authorisation holder for Lotemax in United States?
BAUSCH AND LOMB holds the US marketing authorisation.