SEZABY (phenobarbital sodium)
SEZABY is indicated for the treatment of Neonatal Seizures.
How SEZABY Works
Phenobarbital acts as a non-selective central nervous system (CNS) depressant. It exerts its anticonvulsant effect by binding to the GABA-A receptor complex, which increases the duration of chloride channel openings. This action enhances the inhibitory effects of gamma-aminobutyric acid (GABA), leading to neuronal hyperpolarization and a resulting increase in the seizure threshold.
Details
- Status
- Prescription
- First Approved
- 2022-11-17
- Patent Cliff
- 2042
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
SEZABY Approval History
What SEZABY Treats
1 indicationsSEZABY is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neonatal Seizures
SEZABY Boxed Warning
RISKS FROM CONCOMITANT USE WITH OPIOIDS; DEPENDENCE AND WITHDRAWAL REACTIONS AFTER USE OF SEZABY FOR A LONGER DURATION THAN RECOMMENDED; and ABUSE, MISUSE AND ADDICTION WITH UNAPPROVED USE IN ADOLESCENTS AND ADULTS Risks from Concomitant Use with Opioids Concomitant use of phenobarbital products, including SEZABY, and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options...
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; DEPENDENCE AND WITHDRAWAL REACTIONS AFTER USE OF SEZABY FOR A LONGER DURATION THAN RECOMMENDED; and ABUSE, MISUSE AND ADDICTION WITH UNAPPROVED USE IN ADOLESCENTS AND ADULTS Risks from Concomitant Use with Opioids Concomitant use of phenobarbital products, including SEZABY, and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. If a decision is made for concomitant use of these drugs, limit dosages and durations to the minimum required, and follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Precautions (5.1) and Drug Interactions (7.3)]. Dependence and Withdrawal Reactions After Use of SEZABY for a Longer Duration than Recommended The continued use of phenobarbital may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although SEZABY is indicated only for short-term use [see Indications and Usage (1) and Dosage and Administration (2)], if used for a longer duration than recommended, abrupt discontinuation or rapid dosage reduction of SEZABY may precipitate acute withdrawal reactions, which can be life-threatening. For patients receiving SEZABY for longer duration than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue SEZABY [see Warnings and Precautions (5.2)]. Abuse, Misuse, and Addiction with Unapproved Use in Adolescents and Adults SEZABY is not approved for use in adolescents or adults. The unapproved use of SEZABY, in adolescents and adults exposes them to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of phenobarbital commonly involve concomitant use of other drugs, alcohol, and/or illicit substances, which is associated with an increa
SEZABY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SEZABY FDA Label Details
Indications & Usage
FDA Label (PDF)SEZABY is indicated for the treatment of Neonatal Seizures.
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; DEPENDENCE AND WITHDRAWAL REACTIONS AFTER USE OF SEZABY FOR A LONGER DURATION THAN RECOMMENDED; and ABUSE, MISUSE AND ADDICTION WITH UNAPPROVED USE IN ADOLESCENTS AND ADULTS Risks from Concomitant Use with Opioids Concomitant use of phenobarbital pro...
SEZABY Patents & Exclusivity
Patents (1 active)
Exclusivity
Pro Intelligence Preview
Deep insights for SEZABY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.