🇺🇸 HPN-100 in United States

FDA authorised HPN-100 on 1 February 2013 · 10 US adverse-event reports

Marketing authorisations

FDA — authorised 1 February 2013

  • Application: NDA203284
  • Marketing authorisation holder: HORIZON THERAP US
  • Local brand name: RAVICTI
  • Indication: LIQUID — ORAL
  • Status: approved

Read official source →

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. Hyperammonaemia — 2 reports (20%)
  2. Gastrooesophageal Reflux Disease — 1 report (10%)
  3. Hypoglycaemia — 1 report (10%)
  4. Lethargy — 1 report (10%)
  5. Loss Of Consciousness — 1 report (10%)
  6. Pancytopenia — 1 report (10%)
  7. Pneumonia — 1 report (10%)
  8. Postural Orthostatic Tachycardia Syndrome — 1 report (10%)
  9. Rash — 1 report (10%)

Source database →

HPN-100 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 HPN-100 approved in United States?

Yes. FDA authorised it on 1 February 2013; FDA has authorised it.

Who is the marketing authorisation holder for HPN-100 in United States?

HORIZON THERAP US holds the US marketing authorisation.