🇺🇸 TPOXX in United States

FDA authorised TPOXX on 13 July 2018 · 93 US adverse-event reports

Marketing authorisations

FDA — authorised 13 July 2018

  • Application: NDA208627
  • Marketing authorisation holder: SIGA TECHNOLOGIES
  • Status: approved

FDA — authorised 18 May 2022

  • Application: NDA214518
  • Marketing authorisation holder: SIGA TECHNOLOGIES
  • Status: supplemented

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. Drug Resistance — 19 reports (20.43%)
  2. Headache — 14 reports (15.05%)
  3. Nausea — 14 reports (15.05%)
  4. Fatigue — 12 reports (12.9%)
  5. Diarrhoea — 10 reports (10.75%)
  6. Alanine Aminotransferase Increased — 6 reports (6.45%)
  7. Acute Kidney Injury — 5 reports (5.38%)
  8. Decreased Appetite — 5 reports (5.38%)
  9. Abdominal Pain — 4 reports (4.3%)
  10. Dizziness — 4 reports (4.3%)

Source database →

Other Infectious Disease / Virology approved in United States

Frequently asked questions

Is TPOXX approved in United States?

Yes. FDA authorised it on 13 July 2018; FDA authorised it on 18 May 2022.

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

SIGA TECHNOLOGIES holds the US marketing authorisation.