FDA — authorised 7 December 2001
- Application: NDA021345
- Marketing authorisation holder: MYLAN IRELAND LTD
- Status: supplemented
🇺🇸 FONDAPARINUX SODIUM in United States
FDA authorised FONDAPARINUX SODIUM on 7 December 2001 · 386 US adverse-event reports
Marketing authorisations
FDA — authorised 11 July 2011
- Application: ANDA091316
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: FONDAPARINUX SODIUM
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 26 December 2017
- Application: ANDA206918
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: FONDAPARINUX SODIUM
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 15 May 2018
- Application: ANDA206812
- Marketing authorisation holder: HENGRUI PHARMA
- Local brand name: FONDAPARINUX SODIUM
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 14 November 2018
- Application: ANDA208615
- Marketing authorisation holder: SCINOPHARM TAIWAN
- Local brand name: FONDAPARINUX SODIUM
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 19 August 2024
- Application: ANDA216493
- Marketing authorisation holder: HANGZHOU ZHONGMEI
- Local brand name: FONDAPARINUX SODIUM
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 18 December 2024
- Application: ANDA218312
- Marketing authorisation holder: BRIGHTGENE
- Local brand name: FONDAPARINUX SODIUM
- Indication: SOLUTION — SUBCUTANEOUS
- 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: 386
Most-reported reactions
- Thrombosis — 48 reports (12.44%)
- Pulmonary Embolism — 44 reports (11.4%)
- Drug Ineffective — 42 reports (10.88%)
- Heparin-Induced Thrombocytopenia — 40 reports (10.36%)
- Off Label Use — 39 reports (10.1%)
- Abdominal Pain — 35 reports (9.07%)
- Anaemia — 35 reports (9.07%)
- Deep Vein Thrombosis — 35 reports (9.07%)
- Diarrhoea — 34 reports (8.81%)
- Haemoglobin Decreased — 34 reports (8.81%)
FONDAPARINUX SODIUM 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 FONDAPARINUX SODIUM approved in United States?
Yes. FDA authorised it on 7 December 2001; FDA authorised it on 11 July 2011; FDA authorised it on 26 December 2017.
Who is the marketing authorisation holder for FONDAPARINUX SODIUM in United States?
MYLAN IRELAND LTD holds the US marketing authorisation.