🇺🇸 TENOFOVIR DISOPROXIL FUMARATE in United States

FDA authorised TENOFOVIR DISOPROXIL FUMARATE on 2 March 2018 · 9,874 US adverse-event reports

Marketing authorisations

FDA — authorised 2 March 2018

  • Application: ANDA209498
  • Marketing authorisation holder: QILU
  • Status: supplemented

FDA — authorised 31 July 2018

  • Application: ANDA206481
  • Marketing authorisation holder: CHARTWELL
  • Status: approved

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 4 June 2021

  • Application: ANDA204131
  • Marketing authorisation holder: CHARTWELL RX
  • 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 — 2,135 reports (21.62%)
  2. Maternal Exposure During Pregnancy — 1,709 reports (17.31%)
  3. Virologic Failure — 1,035 reports (10.48%)
  4. Abortion Spontaneous — 896 reports (9.07%)
  5. Pathogen Resistance — 821 reports (8.31%)
  6. Drug Ineffective — 762 reports (7.72%)
  7. Viral Mutation Identified — 755 reports (7.65%)
  8. Osteoporosis — 620 reports (6.28%)
  9. Drug Resistance — 612 reports (6.2%)
  10. Drug Interaction — 529 reports (5.36%)

Source database →

TENOFOVIR DISOPROXIL FUMARATE 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 TENOFOVIR DISOPROXIL FUMARATE approved in United States?

Yes. FDA authorised it on 2 March 2018; FDA authorised it on 31 July 2018; FDA authorised it on 4 September 2018.

Who is the marketing authorisation holder for TENOFOVIR DISOPROXIL FUMARATE in United States?

QILU holds the US marketing authorisation.