🇺🇸 Bonjesta in United States

FDA authorised Bonjesta on 7 November 2016 · 80 US adverse-event reports

Marketing authorisations

FDA — authorised 7 November 2016

  • Application: NDA209661
  • Marketing authorisation holder: DUCHESNAY
  • Local brand name: BONJESTA
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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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. Nausea — 14 reports (17.5%)
  2. Maternal Exposure During Pregnancy — 11 reports (13.75%)
  3. Product Use In Unapproved Indication — 9 reports (11.25%)
  4. Somnolence — 9 reports (11.25%)
  5. Vomiting — 8 reports (10%)
  6. Drug Ineffective — 7 reports (8.75%)
  7. Exposure During Pregnancy — 6 reports (7.5%)
  8. Fatigue — 6 reports (7.5%)
  9. Dizziness — 5 reports (6.25%)
  10. Pregnancy — 5 reports (6.25%)

Source database →

Bonjesta 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 Bonjesta approved in United States?

Yes. FDA authorised it on 7 November 2016; FDA has authorised it.

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

DUCHESNAY holds the US marketing authorisation.