🇺🇸 Sovaldi in United States

FDA authorised Sovaldi on 6 December 2013 · 8,497 US adverse-event reports

Marketing authorisations

FDA — authorised 6 December 2013

  • Application: NDA204671
  • Marketing authorisation holder: GILEAD SCIENCES INC
  • Status: supplemented

FDA — authorised 28 August 2019

  • Application: NDA212480
  • Marketing authorisation holder: GILEAD SCIENCES INC
  • Status: approved

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 — 1,609 reports (18.94%)
  2. Drug Ineffective — 1,212 reports (14.26%)
  3. Headache — 1,095 reports (12.89%)
  4. Nausea — 892 reports (10.5%)
  5. Hepatitis C — 888 reports (10.45%)
  6. Off Label Use — 844 reports (9.93%)
  7. Insomnia — 614 reports (7.23%)
  8. Anaemia — 553 reports (6.51%)
  9. Dyspnoea — 396 reports (4.66%)
  10. Rash — 394 reports (4.64%)

Source database →

Sovaldi in other countries

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

Other Infectious Disease approved in United States

Frequently asked questions

Is Sovaldi approved in United States?

Yes. FDA authorised it on 6 December 2013; FDA authorised it on 28 August 2019; FDA has authorised it.

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

GILEAD SCIENCES INC holds the US marketing authorisation.