🇺🇸 Xospata in United States

FDA authorised Xospata on 28 November 2018 · 1,754 US adverse-event reports

Marketing authorisations

FDA — authorised 28 November 2018

  • Application: NDA211349
  • Marketing authorisation holder: ASTELLAS
  • Status: supplemented

FDA

  • Status: approved

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. Off Label Use — 254 reports (14.48%)
  2. Acute Myeloid Leukaemia — 243 reports (13.85%)
  3. Platelet Count Decreased — 222 reports (12.66%)
  4. Myelosuppression — 207 reports (11.8%)
  5. Death — 168 reports (9.58%)
  6. Pyrexia — 165 reports (9.41%)
  7. Pneumonia — 164 reports (9.35%)
  8. Product Use Issue — 116 reports (6.61%)
  9. Acute Myeloid Leukaemia Recurrent — 109 reports (6.21%)
  10. Hepatic Function Abnormal — 106 reports (6.04%)

Source database →

Xospata 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 Xospata approved in United States?

Yes. FDA authorised it on 28 November 2018; FDA has authorised it.

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

ASTELLAS holds the US marketing authorisation.