🇺🇸 REPAGLINIDE in United States

FDA authorised REPAGLINIDE on 22 November 2013 · 4,081 US adverse-event reports

Marketing authorisations

FDA — authorised 22 November 2013

  • Application: ANDA078555
  • Marketing authorisation holder: CHARTWELL RX
  • Status: approved

FDA — authorised 22 January 2014

  • Application: ANDA203820
  • Marketing authorisation holder: AUROBINDO PHARMA LTD
  • Status: supplemented

FDA — authorised 22 March 2023

  • Application: ANDA207209
  • Marketing authorisation holder: MACLEODS PHARMS LTD
  • 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. Hypoglycaemia — 854 reports (20.93%)
  2. Acute Kidney Injury — 564 reports (13.82%)
  3. Drug Interaction — 453 reports (11.1%)
  4. Diarrhoea — 402 reports (9.85%)
  5. Lactic Acidosis — 373 reports (9.14%)
  6. Nausea — 309 reports (7.57%)
  7. Dyspnoea — 298 reports (7.3%)
  8. Blood Glucose Increased — 292 reports (7.16%)
  9. Asthenia — 273 reports (6.69%)
  10. Vomiting — 263 reports (6.44%)

Source database →

REPAGLINIDE 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 REPAGLINIDE approved in United States?

Yes. FDA authorised it on 22 November 2013; FDA authorised it on 22 January 2014; FDA authorised it on 22 March 2023.

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

CHARTWELL RX holds the US marketing authorisation.