🇺🇸 Infliximab-Dyyb in United States

FDA authorised Infliximab-Dyyb on 20 October 2023 · 1,156 US adverse-event reports

Marketing authorisation

FDA — authorised 20 October 2023

  • Application: BLA761358
  • Marketing authorisation holder: CELLTRION
  • Local brand name: ZYMFENTRA
  • Indication: INJECTABLE — INJECTION
  • 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. Intentional Dose Omission — 293 reports (25.35%)
  2. Intentional Product Use Issue — 169 reports (14.62%)
  3. Off Label Use — 135 reports (11.68%)
  4. Overdose — 93 reports (8.04%)
  5. Crohn^S Disease — 87 reports (7.53%)
  6. Arthralgia — 77 reports (6.66%)
  7. Fatigue — 77 reports (6.66%)
  8. Drug Ineffective — 76 reports (6.57%)
  9. Nausea — 75 reports (6.49%)
  10. Headache — 74 reports (6.4%)

Source database →

Infliximab-Dyyb in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Immunology approved in United States

Frequently asked questions

Is Infliximab-Dyyb approved in United States?

Yes. FDA authorised it on 20 October 2023.

Who is the marketing authorisation holder for Infliximab-Dyyb in United States?

CELLTRION holds the US marketing authorisation.