🇺🇸 Genvoya in United States

FDA authorised Genvoya on 5 November 2015 · 24,055 US adverse-event reports

Marketing authorisations

FDA — authorised 5 November 2015

  • Application: NDA207561
  • Marketing authorisation holder: GILEAD SCIENCES INC
  • Local brand name: GENVOYA
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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 — 4,493 reports (18.68%)
  2. Chronic Kidney Disease — 2,605 reports (10.83%)
  3. Bone Loss — 2,411 reports (10.02%)
  4. Osteonecrosis — 2,379 reports (9.89%)
  5. Tooth Loss — 2,247 reports (9.34%)
  6. Multiple Fractures — 2,132 reports (8.86%)
  7. Renal Failure — 2,086 reports (8.67%)
  8. Osteoporosis — 1,928 reports (8.01%)
  9. Renal Injury — 1,917 reports (7.97%)
  10. Pain — 1,857 reports (7.72%)

Source database →

Genvoya 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 Genvoya approved in United States?

Yes. FDA authorised it on 5 November 2015; FDA has authorised it.

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

GILEAD SCIENCES INC holds the US marketing authorisation.