🇺🇸 IVABRADINE HYDROCHLORIDE in United States

FDA authorised IVABRADINE HYDROCHLORIDE on 30 December 2021 · 610 US adverse-event reports

Marketing authorisations

FDA — authorised 30 December 2021

  • Application: ANDA214051
  • Marketing authorisation holder: INGENUS PHARMS LLC
  • Local brand name: IVABRADINE HYDROCHLORIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 5 October 2022

  • Application: ANDA213366
  • Marketing authorisation holder: ANNORA PHARMA
  • Local brand name: IVABRADINE HYDROCHLORIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 5 September 2024

  • Application: ANDA213276
  • Marketing authorisation holder: BIONPHARMA
  • Local brand name: IVABRADINE HYDROCHLORIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 8 November 2024

  • Application: ANDA215238
  • Marketing authorisation holder: ALEMBIC
  • Local brand name: IVABRADINE HYDROCHLORIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 28 April 2025

  • Application: ANDA213483
  • Marketing authorisation holder: MSN
  • Local brand name: IVABRADINE HYDROCHLORIDE
  • Indication: TABLET — 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. Dyspnoea — 114 reports (18.69%)
  2. Cardiac Failure — 85 reports (13.93%)
  3. Drug Ineffective — 64 reports (10.49%)
  4. Hypotension — 60 reports (9.84%)
  5. Off Label Use — 54 reports (8.85%)
  6. Drug Interaction — 51 reports (8.36%)
  7. Cardiac Disorder — 48 reports (7.87%)
  8. Anaemia — 46 reports (7.54%)
  9. Angina Pectoris — 44 reports (7.21%)
  10. Death — 44 reports (7.21%)

Source database →

IVABRADINE HYDROCHLORIDE 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 IVABRADINE HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 30 December 2021; FDA authorised it on 5 October 2022; FDA authorised it on 5 September 2024.

Who is the marketing authorisation holder for IVABRADINE HYDROCHLORIDE in United States?

INGENUS PHARMS LLC holds the US marketing authorisation.