🇺🇸 Veklury in United States

FDA authorised Veklury on 22 October 2020 · 1,446 US adverse-event reports

Marketing authorisations

FDA — authorised 22 October 2020

  • Application: NDA214787
  • Marketing authorisation holder: GILEAD SCIENCES INC
  • Local brand name: VEKLURY
  • Indication: POWDER — INTRAVENOUS
  • 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. Death — 269 reports (18.6%)
  2. Covid-19 — 246 reports (17.01%)
  3. Bradycardia — 189 reports (13.07%)
  4. Off Label Use — 136 reports (9.41%)
  5. Covid-19 Pneumonia — 127 reports (8.78%)
  6. Drug Ineffective — 113 reports (7.81%)
  7. Renal Impairment — 104 reports (7.19%)
  8. Pneumonia — 103 reports (7.12%)
  9. Respiratory Failure — 84 reports (5.81%)
  10. Hepatic Function Abnormal — 75 reports (5.19%)

Source database →

Veklury in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is Veklury approved in United States?

Yes. FDA authorised it on 22 October 2020; FDA has authorised it.

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

GILEAD SCIENCES INC holds the US marketing authorisation.