🇺🇸 ibalizumab-uiyk in United States

FDA authorised ibalizumab-uiyk on 6 March 2018 · 31 US adverse-event reports

Marketing authorisation

FDA — authorised 6 March 2018

  • Application: BLA761065
  • Marketing authorisation holder: THERATECHNOLOGIES
  • Local brand name: TROGARZO
  • 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. Drug Ineffective — 4 reports (12.9%)
  2. Off Label Use — 4 reports (12.9%)
  3. Blood Hiv Rna Increased — 3 reports (9.68%)
  4. Dyspepsia — 3 reports (9.68%)
  5. Genotype Drug Resistance Test Positive — 3 reports (9.68%)
  6. Hepatic Cytolysis — 3 reports (9.68%)
  7. Hepatitis B — 3 reports (9.68%)
  8. Hepatitis B Dna Increased — 3 reports (9.68%)
  9. Pruritus — 3 reports (9.68%)
  10. Anhedonia — 2 reports (6.45%)

Source database →

ibalizumab-uiyk in other countries

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

Other Infectious Disease approved in United States

Frequently asked questions

Is ibalizumab-uiyk approved in United States?

Yes. FDA authorised it on 6 March 2018.

Who is the marketing authorisation holder for ibalizumab-uiyk in United States?

THERATECHNOLOGIES holds the US marketing authorisation.