🇺🇸 Lymphoseek in United States

FDA authorised Lymphoseek on 13 March 2013 · 219 US adverse-event reports

Marketing authorisations

FDA — authorised 13 March 2013

  • Application: NDA202207
  • Marketing authorisation holder: CARDINAL HEALTH 414
  • 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. Drug Ineffective — 123 reports (56.16%)
  2. Off Label Use — 47 reports (21.46%)
  3. Injection Site Pain — 14 reports (6.39%)
  4. Rash — 12 reports (5.48%)
  5. Medication Error — 5 reports (2.28%)
  6. Erythema — 4 reports (1.83%)
  7. Product Preparation Error — 4 reports (1.83%)
  8. Radioisotope Uptake Increased — 4 reports (1.83%)
  9. Drug Dispensing Error — 3 reports (1.37%)
  10. Incorrect Dose Administered — 3 reports (1.37%)

Source database →

Lymphoseek in other countries

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

Other Other approved in United States

Frequently asked questions

Is Lymphoseek approved in United States?

Yes. FDA authorised it on 13 March 2013; FDA has authorised it.

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

CARDINAL HEALTH 414 holds the US marketing authorisation.