🇺🇸 Efavirenz, lamivudine, and tenofovir in United States

FDA authorised Efavirenz, lamivudine, and tenofovir on 14 May 2020 · 15 US adverse-event reports

Marketing authorisations

FDA — authorised 14 May 2020

  • Application: ANDA213038
  • Marketing authorisation holder: LAURUS
  • Status: approved

FDA — authorised 14 May 2020

  • Application: ANDA212786
  • Marketing authorisation holder: LAURUS
  • 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. Foetal Exposure During Pregnancy — 3 reports (20%)
  2. Headache — 2 reports (13.33%)
  3. Pyrexia — 2 reports (13.33%)
  4. Virologic Failure — 2 reports (13.33%)
  5. Abdominal Pain — 1 report (6.67%)
  6. Abortion Spontaneous — 1 report (6.67%)
  7. Anaemia — 1 report (6.67%)
  8. Anogenital Warts — 1 report (6.67%)
  9. Asthenia — 1 report (6.67%)
  10. Blindness — 1 report (6.67%)

Source database →

Efavirenz, lamivudine, and tenofovir 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 Efavirenz, lamivudine, and tenofovir approved in United States?

Yes. FDA authorised it on 14 May 2020; FDA authorised it on 14 May 2020; FDA has authorised it.

Who is the marketing authorisation holder for Efavirenz, lamivudine, and tenofovir in United States?

LAURUS holds the US marketing authorisation.