🇺🇸 Harvoni in United States

FDA authorised Harvoni on 10 October 2014 · 14,153 US adverse-event reports

Marketing authorisations

FDA — authorised 10 October 2014

  • Application: NDA205834
  • Marketing authorisation holder: GILEAD SCIENCES INC
  • Status: supplemented

FDA — authorised 28 August 2019

  • Application: NDA212477
  • Marketing authorisation holder: GILEAD SCIENCES INC
  • Local brand name: HARVONI
  • Indication: PELLETS — ORAL
  • Status: approved

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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. Fatigue — 4,130 reports (29.18%)
  2. Headache — 3,706 reports (26.19%)
  3. Nausea — 1,239 reports (8.75%)
  4. Drug Ineffective — 1,136 reports (8.03%)
  5. Diarrhoea — 913 reports (6.45%)
  6. Hepatitis C — 878 reports (6.2%)
  7. Insomnia — 835 reports (5.9%)
  8. Vomiting — 441 reports (3.12%)
  9. Dizziness — 439 reports (3.1%)
  10. Drug Dose Omission — 436 reports (3.08%)

Source database →

Harvoni 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 Harvoni approved in United States?

Yes. FDA authorised it on 10 October 2014; FDA authorised it on 28 August 2019; FDA has authorised it.

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

GILEAD SCIENCES INC holds the US marketing authorisation.