🇺🇸 Emtricitabine and Tenofovir in United States

FDA authorised Emtricitabine and Tenofovir on 4 September 2018 · 274 US adverse-event reports

Marketing authorisations

FDA — authorised 4 September 2018

  • Application: ANDA203041
  • Marketing authorisation holder: AUROBINDO PHARMA
  • Status: supplemented

FDA — authorised 3 June 2019

  • Application: ANDA206894
  • Marketing authorisation holder: CIPLA
  • Status: supplemented

FDA — authorised 2 April 2021

  • Application: ANDA090958
  • Marketing authorisation holder: CIPLA
  • Status: supplemented

FDA — authorised 4 June 2021

  • Application: ANDA204131
  • Marketing authorisation holder: CHARTWELL RX
  • Status: approved

FDA — authorised 24 January 2022

  • Application: ANDA203053
  • Marketing authorisation holder: HETERO LABS LTD V
  • 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 — 76 reports (27.74%)
  2. Exposure During Pregnancy — 41 reports (14.96%)
  3. Death — 27 reports (9.85%)
  4. Maternal Exposure During Pregnancy — 26 reports (9.49%)
  5. Abortion Spontaneous — 24 reports (8.76%)
  6. Diarrhoea — 18 reports (6.57%)
  7. Drug Interaction — 17 reports (6.2%)
  8. Anaemia — 15 reports (5.47%)
  9. Pyrexia — 15 reports (5.47%)
  10. Vomiting — 15 reports (5.47%)

Source database →

Other Infectious Disease / Virology approved in United States

Frequently asked questions

Is Emtricitabine and Tenofovir approved in United States?

Yes. FDA authorised it on 4 September 2018; FDA authorised it on 3 June 2019; FDA authorised it on 2 April 2021.

Who is the marketing authorisation holder for Emtricitabine and Tenofovir in United States?

AUROBINDO PHARMA holds the US marketing authorisation.