FDA — authorised 11 August 2017
- Application: ANDA090978
- Marketing authorisation holder: NATCO PHARMA LTD
- Local brand name: LANTHANUM CARBONATE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
🇺🇸 Phosphorus binder in United States
FDA authorised Phosphorus binder on 11 August 2017 · 10 US adverse-event reports
Marketing authorisations
FDA — authorised 24 January 2022
- Application: ANDA206868
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: LANTHANUM CARBONATE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 27 January 2022
- Application: ANDA090977
- Marketing authorisation holder: BARR
- Local brand name: LANTHANUM CARBONATE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 13 March 2025
- Application: ANDA202329
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: LANTHANUM CARBONATE
- Indication: TABLET, CHEWABLE — 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: 23 April 2025 – 23 April 2026
- Total reports: 10
Most-reported reactions
- Aortic Valve Incompetence — 1 report (10%)
- Asthenia — 1 report (10%)
- Cardiac Disorder — 1 report (10%)
- Cardio-Respiratory Arrest — 1 report (10%)
- Cardioactive Drug Level Above Therapeutic — 1 report (10%)
- Chest Discomfort — 1 report (10%)
- Chest Pain — 1 report (10%)
- Coronary Artery Disease — 1 report (10%)
- Decreased Appetite — 1 report (10%)
- Dialysis — 1 report (10%)
Other Nephrology approved in United States
Frequently asked questions
Is Phosphorus binder approved in United States?
Yes. FDA authorised it on 11 August 2017; FDA authorised it on 24 January 2022; FDA authorised it on 27 January 2022.
Who is the marketing authorisation holder for Phosphorus binder in United States?
NATCO PHARMA LTD holds the US marketing authorisation.