🇺🇸 INOTUZUMAB OZOGAMICIN in United States

FDA authorised INOTUZUMAB OZOGAMICIN on 6 March 2024 · 1,471 US adverse-event reports

Marketing authorisation

FDA — authorised 6 March 2024

  • Application: BLA761040
  • Marketing authorisation holder: WYETH PHARMS INC
  • Indication: Efficacy
  • Status: approved

The FDA approved INOTUZUMAB OZOGAMICIN for its approved indication on 6 March 2024. The marketing authorisation was granted to WYETH PHARMS INC through a standard expedited pathway. The application number for this approval is BLA761040.

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. Febrile Neutropenia — 224 reports (15.23%)
  2. Death — 184 reports (12.51%)
  3. Venoocclusive Liver Disease — 168 reports (11.42%)
  4. Pyrexia — 144 reports (9.79%)
  5. Off Label Use — 143 reports (9.72%)
  6. Drug Ineffective — 133 reports (9.04%)
  7. Acute Lymphocytic Leukaemia Recurrent — 131 reports (8.91%)
  8. Cytokine Release Syndrome — 117 reports (7.95%)
  9. Sepsis — 117 reports (7.95%)
  10. Thrombocytopenia — 110 reports (7.48%)

Source database →

INOTUZUMAB OZOGAMICIN in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is INOTUZUMAB OZOGAMICIN approved in United States?

Yes. FDA authorised it on 6 March 2024.

Who is the marketing authorisation holder for INOTUZUMAB OZOGAMICIN in United States?

WYETH PHARMS INC holds the US marketing authorisation.