🇺🇸 GSK1265744 in United States

FDA authorised GSK1265744 on 14 June 2021 · 7 US adverse-event reports

Marketing authorisations

FDA — authorised 14 June 2021

  • Application: ANDA214196
  • Marketing authorisation holder: AMNEAL
  • Local brand name: ETRAVIRINE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 13 April 2022

  • Application: ANDA215402
  • Marketing authorisation holder: CARNEGIE
  • Local brand name: ETRAVIRINE
  • Indication: TABLET — ORAL
  • Status: approved

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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. Amylase Increased — 1 report (14.29%)
  2. Headache — 1 report (14.29%)
  3. Insomnia — 1 report (14.29%)
  4. Mesenteric Vein Thrombosis — 1 report (14.29%)
  5. Nausea — 1 report (14.29%)
  6. Portal Vein Thrombosis — 1 report (14.29%)
  7. Splenic Vein Thrombosis — 1 report (14.29%)

Source database →

Frequently asked questions

Is GSK1265744 approved in United States?

Yes. FDA authorised it on 14 June 2021; FDA authorised it on 13 April 2022.

Who is the marketing authorisation holder for GSK1265744 in United States?

AMNEAL holds the US marketing authorisation.