🇺🇸 Levodopa-carbidopa intestinal gel in United States

FDA authorised Levodopa-carbidopa intestinal gel on 9 January 2015 · 26 US adverse-event reports

Marketing authorisation

FDA — authorised 9 January 2015

  • Application: NDA203952
  • Marketing authorisation holder: ABBVIE
  • Local brand name: DUOPA
  • Indication: SUSPENSION — ENTERAL
  • 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 — 3 reports (11.54%)
  2. Constipation — 3 reports (11.54%)
  3. Dehydration — 3 reports (11.54%)
  4. Ileus Paralytic — 3 reports (11.54%)
  5. Pneumonia — 3 reports (11.54%)
  6. Vomiting — 3 reports (11.54%)
  7. Confusional State — 2 reports (7.69%)
  8. Hyponatraemia — 2 reports (7.69%)
  9. Parkinsonism Hyperpyrexia Syndrome — 2 reports (7.69%)
  10. Toxic Encephalopathy — 2 reports (7.69%)

Source database →

Other Neurology approved in United States

Frequently asked questions

Is Levodopa-carbidopa intestinal gel approved in United States?

Yes. FDA authorised it on 9 January 2015.

Who is the marketing authorisation holder for Levodopa-carbidopa intestinal gel in United States?

ABBVIE holds the US marketing authorisation.