Prescription medicine
Remimazolam Brand names: Byfavo
Remimazolam (Byfavo) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the remimazolam FDA label on DailyMed (effective February 20, 2025, Acacia Pharma, Ltd.); the NDA 212295 record on Drugs@FDA; every remimazolam label on DailyMed.
Highlights of the record
FDA label of February 20, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION, AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS.
See full prescribing information for complete boxed warning Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO. ( 2.1 , 5.1 ) Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. ( 2.1 , 5.1 ) BYFAVO has been associated with hypoxia, bradycardia, and hypotension. Continuously monitor vital signs during sedation and through the recovery period. ( 2.1 , 5.1 ) Resuscitative drugs, and age- and size-appropriate equipment for bag/valve/mask assisted ventilation must be immediately available during administration of BYFAVO. ( 2.1 , 5.1 ) Concomitant use of benzodiazepines with opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative effect of intravenous BYFAVO can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. […]
Used for
From the label: indications and usageBYFAVO ® is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
Forms and strengths
- 2.5 mg/ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- July 2, 2020 Byfavo, Acacia; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 13, 2034 Byfavo injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 106 through July 30, 2026
What is remimazolam used for?
From the label: indications and usageBYFAVO ® is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. BYFAVO (remimazolam) for injection is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
Source: FDA drug label (BYFAVO), Acacia Pharma, Ltd., effective February 20, 2025 (SPL set 4e1838f2-b999-41a7-a761-d94f09aa531f), via openFDA; the full label on DailyMed
Is there a generic for remimazolam (Byfavo)?
No generic remimazolam is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 11 patents for Byfavo injection, the last expiring on January 13, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the remimazolam label say about other medicines?
The remimazolam label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Dextran 40 | contraindications | CONTRAINDICATIONS BYFAVO is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40 [see Warnings and Precautions (5.3) ]. |
| Flumazenil | warnings and precautions | A benzodiazepine reversal agent (flumazenil) should be immediately available during administration of BYFAVO [see Overdosage (10) ]. |
| Propofol | boxed warning | The sedative effect of intravenous BYFAVO can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. |
Source: FDA drug label (BYFAVO), Acacia Pharma, Ltd., effective February 20, 2025 (SPL set 4e1838f2-b999-41a7-a761-d94f09aa531f), via openFDA; the full label on DailyMed
What do FAERS reports show for remimazolam?
The FDA Adverse Event Reporting System holds 106 reports that list remimazolam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 12 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Remimazolam side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other