🇺🇸 177Lu-DOTA0-Tyr3-Octreotate in United States

FDA authorised 177Lu-DOTA0-Tyr3-Octreotate on 26 January 2018 · 10 US adverse-event reports

Marketing authorisation

FDA — authorised 26 January 2018

  • Application: NDA208700
  • Marketing authorisation holder: AAA USA INC
  • Local brand name: LUTATHERA
  • Indication: SOLUTION — INTRAVENOUS
  • 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. Abdominal Pain Upper — 1 report (10%)
  2. Arrhythmia — 1 report (10%)
  3. Cholangitis — 1 report (10%)
  4. Dyspnoea — 1 report (10%)
  5. Head Injury — 1 report (10%)
  6. Intraductal Proliferative Breast Lesion — 1 report (10%)
  7. Left Ventricular Dysfunction — 1 report (10%)
  8. Malaise — 1 report (10%)
  9. Malignant Neoplasm Progression — 1 report (10%)
  10. Productive Cough — 1 report (10%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is 177Lu-DOTA0-Tyr3-Octreotate approved in United States?

Yes. FDA authorised it on 26 January 2018.

Who is the marketing authorisation holder for 177Lu-DOTA0-Tyr3-Octreotate in United States?

AAA USA INC holds the US marketing authorisation.