🇺🇸 Tc 99m tilmanocept in United States

FDA authorised Tc 99m tilmanocept on 13 March 2013 · 11 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. Erythema — 2 reports (18.18%)
  2. Abscess — 1 report (9.09%)
  3. Arterial Haemorrhage — 1 report (9.09%)
  4. Cellulitis — 1 report (9.09%)
  5. Discomfort — 1 report (9.09%)
  6. Drain Site Complication — 1 report (9.09%)
  7. Gram Stain Positive — 1 report (9.09%)
  8. Haemorrhage — 1 report (9.09%)
  9. Incision Site Swelling — 1 report (9.09%)
  10. Mouth Haemorrhage — 1 report (9.09%)

Source database →

Tc 99m tilmanocept in other countries

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

Frequently asked questions

Is Tc 99m tilmanocept approved in United States?

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

Who is the marketing authorisation holder for Tc 99m tilmanocept in United States?

CARDINAL HEALTH 414 holds the US marketing authorisation.