🇺🇸 APRETUDE in United States

FDA authorised APRETUDE on 20 December 2021 · 22 US adverse-event reports

Marketing authorisations

FDA — authorised 20 December 2021

  • Application: NDA215499
  • Marketing authorisation holder: VIIV HLTHCARE
  • 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. Injection Site Pain — 5 reports (22.73%)
  2. Dizziness — 2 reports (9.09%)
  3. Gait Disturbance — 2 reports (9.09%)
  4. Influenza Like Illness — 2 reports (9.09%)
  5. Nausea — 2 reports (9.09%)
  6. Pyrexia — 2 reports (9.09%)
  7. Rash Pruritic — 2 reports (9.09%)
  8. Therapy Interrupted — 2 reports (9.09%)
  9. Vomiting — 2 reports (9.09%)
  10. Abdominal Pain — 1 report (4.55%)

Source database →

APRETUDE in other countries

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

Frequently asked questions

Is APRETUDE approved in United States?

Yes. FDA authorised it on 20 December 2021; FDA has authorised it.

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

VIIV HLTHCARE holds the US marketing authorisation.