🇺🇸 thiazolidinediones in United States

FDA authorised thiazolidinediones on 29 January 1997 · 24 US adverse-event reports

Marketing authorisations

FDA — authorised 29 January 1997

  • Application: NDA020719
  • Marketing authorisation holder: SANKYO
  • Local brand name: PRELAY
  • 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. Completed Suicide — 9 reports (37.5%)
  2. Death — 5 reports (20.83%)
  3. Diabetic Ketoacidosis — 2 reports (8.33%)
  4. Toxicity To Various Agents — 2 reports (8.33%)
  5. Abdominal Discomfort — 1 report (4.17%)
  6. Accidental Exposure To Product — 1 report (4.17%)
  7. Accidental Exposure To Product By Child — 1 report (4.17%)
  8. Agitation — 1 report (4.17%)
  9. Alanine Aminotransferase Increased — 1 report (4.17%)
  10. Anaemia — 1 report (4.17%)

Source database →

Other Other approved in United States

Frequently asked questions

Is thiazolidinediones approved in United States?

Yes. FDA authorised it on 29 January 1997; FDA has authorised it.

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

SANKYO holds the US marketing authorisation.