🇺🇸 Biktarvy in United States

FDA authorised Biktarvy on 7 February 2018 · 34,160 US adverse-event reports

Marketing authorisations

FDA — authorised 7 February 2018

  • Application: NDA210251
  • Marketing authorisation holder: GILEAD SCIENCES INC
  • 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. Bone Density Decreased — 6,536 reports (19.13%)
  2. Chronic Kidney Disease — 3,595 reports (10.52%)
  3. Bone Loss — 3,432 reports (10.05%)
  4. Tooth Loss — 3,376 reports (9.88%)
  5. Osteonecrosis — 3,354 reports (9.82%)
  6. Multiple Fractures — 3,122 reports (9.14%)
  7. Renal Failure — 2,982 reports (8.73%)
  8. Osteoporosis — 2,751 reports (8.05%)
  9. Pain — 2,532 reports (7.41%)
  10. Renal Injury — 2,480 reports (7.26%)

Source database →

Biktarvy in other countries

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

Other Other approved in United States

Frequently asked questions

Is Biktarvy approved in United States?

Yes. FDA authorised it on 7 February 2018; FDA has authorised it.

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

GILEAD SCIENCES INC holds the US marketing authorisation.