FDA — authorised 12 November 2020
- Application: ANDA209567
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: SORAFENIB TOSYLATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 SORAFENIB TOSYLATE in United States
FDA authorised SORAFENIB TOSYLATE on 12 November 2020 · 53 US adverse-event reports
Marketing authorisations
FDA — authorised 7 June 2022
- Application: ANDA216073
- Marketing authorisation holder: DR REDDYS
- Local brand name: SORAFENIB TOSYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 November 2022
- Application: ANDA209050
- Marketing authorisation holder: YABAO PHARM
- Local brand name: SORAFENIB TOSYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 April 2023
- Application: ANDA217095
- Marketing authorisation holder: TORRENT
- Local brand name: SORAFENIB TOSYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2025
- Application: ANDA212228
- Marketing authorisation holder: APOTEX
- Local brand name: SORAFENIB TOSYLATE
- Indication: TABLET — ORAL
- 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: 53
Most-reported reactions
- Myelosuppression — 12 reports (22.64%)
- Pyrexia — 8 reports (15.09%)
- Pneumonia Legionella — 6 reports (11.32%)
- Asthenia — 5 reports (9.43%)
- Respiratory Failure — 5 reports (9.43%)
- Palmar-Plantar Erythrodysaesthesia Syndrome — 4 reports (7.55%)
- Shock — 4 reports (7.55%)
- Anaemia — 3 reports (5.66%)
- Aspartate Aminotransferase Increased — 3 reports (5.66%)
- Blood Bilirubin Increased — 3 reports (5.66%)
SORAFENIB TOSYLATE 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 SORAFENIB TOSYLATE approved in United States?
Yes. FDA authorised it on 12 November 2020; FDA authorised it on 7 June 2022; FDA authorised it on 9 November 2022.
Who is the marketing authorisation holder for SORAFENIB TOSYLATE in United States?
TEVA PHARMS USA INC holds the US marketing authorisation.