🇺🇸 Vemlidy in United States

FDA authorised Vemlidy on 10 November 2016 · 847 US adverse-event reports

Marketing authorisations

FDA — authorised 10 November 2016

  • Application: NDA208464
  • Marketing authorisation holder: GILEAD SCIENCES INC
  • 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. Product Dose Omission Issue — 128 reports (15.11%)
  2. Death — 120 reports (14.17%)
  3. Off Label Use — 102 reports (12.04%)
  4. Fatigue — 91 reports (10.74%)
  5. Headache — 76 reports (8.97%)
  6. Drug Ineffective — 70 reports (8.26%)
  7. Product Dose Omission — 70 reports (8.26%)
  8. Intentional Dose Omission — 65 reports (7.67%)
  9. Product Use Issue — 63 reports (7.44%)
  10. Diarrhoea — 62 reports (7.32%)

Source database →

Vemlidy 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 Vemlidy approved in United States?

Yes. FDA authorised it on 10 November 2016; FDA has authorised it.

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

GILEAD SCIENCES INC holds the US marketing authorisation.