🇺🇸 CISATRACURIUM BESYLATE in United States

FDA authorised CISATRACURIUM BESYLATE on 24 April 2019 · 368 US adverse-event reports

Marketing authorisations

FDA — authorised 24 April 2019

  • Application: ANDA209132
  • Marketing authorisation holder: SOMERSET
  • Status: approved

FDA — authorised 8 May 2020

  • Application: ANDA209144
  • Marketing authorisation holder: EUGIA PHARMA
  • Status: approved

FDA — authorised 24 May 2022

  • Application: ANDA215516
  • Marketing authorisation holder: GLAND
  • Status: approved

FDA — authorised 28 June 2022

  • Application: ANDA203078
  • Marketing authorisation holder: HIKMA
  • Status: supplemented

FDA — authorised 19 April 2023

  • Application: ANDA203079
  • Marketing authorisation holder: HIKMA
  • 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. Anaesthetic Complication Neurological — 110 reports (29.89%)
  2. Anaphylactic Shock — 73 reports (19.84%)
  3. Drug Ineffective — 34 reports (9.24%)
  4. Hypotension — 30 reports (8.15%)
  5. Hypoxia — 24 reports (6.52%)
  6. Hyperthermia Malignant — 23 reports (6.25%)
  7. Toxic Epidermal Necrolysis — 22 reports (5.98%)
  8. Cyanosis — 18 reports (4.89%)
  9. Hypokalaemia — 17 reports (4.62%)
  10. Tachycardia — 17 reports (4.62%)

Source database →

CISATRACURIUM BESYLATE 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 CISATRACURIUM BESYLATE approved in United States?

Yes. FDA authorised it on 24 April 2019; FDA authorised it on 8 May 2020; FDA authorised it on 24 May 2022.

Who is the marketing authorisation holder for CISATRACURIUM BESYLATE in United States?

SOMERSET holds the US marketing authorisation.