FDA — authorised 18 May 2010
- Application: NDA022548
- Marketing authorisation holder: ABBVIE
- Local brand name: ZYMAXID
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Zymar in United States
FDA authorised Zymar on 18 May 2010 · 743 US adverse-event reports
Marketing authorisations
FDA — authorised 28 August 2013
- Application: ANDA202653
- Marketing authorisation holder: LUPIN
- Local brand name: GATIFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 3 September 2014
- Application: ANDA203189
- Marketing authorisation holder: HIKMA
- Local brand name: GATIFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 11 July 2016
- Application: ANDA204227
- Marketing authorisation holder: SANDOZ
- Local brand name: GATIFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 8 June 2018
- Application: ANDA206446
- Marketing authorisation holder: RISING
- Local brand name: GATIFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 3 November 2021
- Application: ANDA213542
- Marketing authorisation holder: CAPLIN
- Local brand name: GATIFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA203190
- Marketing authorisation holder: HI-TECH PHARMACAL
- Local brand name: GATIFLOXACIN
- Indication: SOLUTION — OPHTHALMIC
- 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: 743
Most-reported reactions
- Hypoglycaemia — 157 reports (21.13%)
- Hyperglycaemia — 104 reports (14%)
- Anaphylactic Reaction — 70 reports (9.42%)
- Diarrhoea — 70 reports (9.42%)
- Drug Intolerance — 68 reports (9.15%)
- Rash — 59 reports (7.94%)
- Dizziness — 58 reports (7.81%)
- Dyspnoea — 55 reports (7.4%)
- Eye Pain — 52 reports (7%)
- Nausea — 50 reports (6.73%)
Zymar in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Zymar approved in United States?
Yes. FDA authorised it on 18 May 2010; FDA authorised it on 28 August 2013; FDA authorised it on 3 September 2014.
Who is the marketing authorisation holder for Zymar in United States?
ABBVIE holds the US marketing authorisation.