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Byfavo FDA Approval History

Last updated by Judith Stewart, BPharm on July 27, 2020.

FDA Approved: Yes (First approved July 2, 2020)
Brand name: Byfavo
Generic name: remimazolam
Dosage form: Injection
Company: Cosmo Pharmaceuticals NV
Treatment for: Sedation

Byfavo (remimazolam) is an ultra-short-acting, intravenous benzodiazepine sedative/anesthetic for the induction and maintenance of procedural sedation in adults.

  • Byfavo is a very rapid onset/offset sedative for use during invasive medical procedures lasting 30 minutes or less, such as colonoscopy and bronchoscopy.
  • Byfavo is administered via intravenous push injection.
  • The Byfavo product label includes a Boxed Warning regarding appropriate training of personnel and equipment that must be available for monitoring and resuscitation during the sedation and recovery periods of the procedure, and also addresses risks from concomitant use of Byfavo with opioid analgesics and other sedative hypnotics.
  • Common adverse reactions (>10%) include hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension.

Development timeline for Byfavo

Jul  2, 2020Approval FDA Approves Byfavo (remimazolam injection) for the Induction and Maintenance of Procedural Sedation
Apr  9, 2019Cosmo Pharmaceuticals Announces Submission of Remimazolam NDA to FDA

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.