🇺🇸 TEPOTINIB in United States

FDA authorised TEPOTINIB on 23 March 2023 · 189 US adverse-event reports

Marketing authorisation

FDA — authorised 23 March 2023

  • Application: NDA214096
  • Marketing authorisation holder: EMD SERONO INC
  • Indication: Labeling
  • Status: approved

Read official source →

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.

Most-reported reactions

  1. Oedema Peripheral — 40 reports (21.16%)
  2. Disease Progression — 26 reports (13.76%)
  3. Death — 23 reports (12.17%)
  4. Off Label Use — 22 reports (11.64%)
  5. Malignant Neoplasm Progression — 20 reports (10.58%)
  6. Renal Impairment — 15 reports (7.94%)
  7. Oedema — 13 reports (6.88%)
  8. Blood Creatinine Increased — 11 reports (5.82%)
  9. Diarrhoea — 10 reports (5.29%)
  10. Drug Ineffective — 9 reports (4.76%)

Source database →

TEPOTINIB 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 TEPOTINIB approved in United States?

Yes. FDA authorised it on 23 March 2023.

Who is the marketing authorisation holder for TEPOTINIB in United States?

EMD SERONO INC holds the US marketing authorisation.