FDA — authorised 6 October 2020
- Application: ANDA212548
- Marketing authorisation holder: XIROMED
- Local brand name: FOSFOMYCIN TROMETHAMINE
- Indication: FOR SOLUTION — ORAL
- Status: approved
🇺🇸 FOSFOMYCIN TROMETHAMINE in United States
FDA authorised FOSFOMYCIN TROMETHAMINE on 6 October 2020 · 594 US adverse-event reports
Marketing authorisations
FDA — authorised 21 October 2021
- Application: ANDA214554
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: FOSFOMYCIN TROMETHAMINE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 26 January 2022
- Application: ANDA211881
- Marketing authorisation holder: CIPLA
- Local brand name: FOSFOMYCIN TROMETHAMINE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 25 March 2024
- Application: ANDA216600
- Marketing authorisation holder: AMNEAL
- Local brand name: FOSFOMYCIN TROMETHAMINE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 3 June 2025
- Application: ANDA217187
- Marketing authorisation holder: PRECISION DOSE INC
- Local brand name: FOSFOMYCIN TROMETHAMINE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 14 November 2025
- Application: ANDA217608
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: FOSFOMYCIN TROMETHAMINE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 9 April 2026
- Application: ANDA217772
- Marketing authorisation holder: AUCTA
- Local brand name: FOSFOMYCIN TROMETHAMINE
- Indication: FOR SOLUTION — ORAL
- 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: 594
Most-reported reactions
- Diarrhoea — 82 reports (13.8%)
- Nausea — 72 reports (12.12%)
- Off Label Use — 68 reports (11.45%)
- Dyspnoea — 67 reports (11.28%)
- Dizziness — 61 reports (10.27%)
- Vomiting — 56 reports (9.43%)
- Urinary Tract Infection — 50 reports (8.42%)
- Product Use Issue — 48 reports (8.08%)
- Fatigue — 47 reports (7.91%)
- Headache — 43 reports (7.24%)
FOSFOMYCIN TROMETHAMINE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is FOSFOMYCIN TROMETHAMINE approved in United States?
Yes. FDA authorised it on 6 October 2020; FDA authorised it on 21 October 2021; FDA authorised it on 26 January 2022.
Who is the marketing authorisation holder for FOSFOMYCIN TROMETHAMINE in United States?
XIROMED holds the US marketing authorisation.