Sezaby FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 30, 2022.
FDA Approved: Yes (First approved November 17, 2022)
Brand name: Sezaby
Generic name: phenobarbital sodium
Dosage form: Powder for Injection
Company: Sun Pharmaceutical Industries Inc.
Treatment for: Neonatal Seizures
Sezaby (phenobarbital sodium) is a barbiturate indicated for the treatment of neonatal seizures in term and preterm infants.
- Sezaby is the first and only product specifically indicated in the U.S. for the treatment of neonatal seizures in term and preterm infants.
- Sezaby is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection.
- Sezaby is administered via intravenous infusion.
- The approval of Sezaby was based on the results of the randomized, controlled trial NEOLEV2, a phase 2 study that compared the incidence of recurrent seizures in neonates treated with phenobarbital vs. levetiracetam in 94 neonates. Twenty-four hours following the administration of phenobarbital or levetiracetam, 73% vs. 25% were seizure-free in the respective groups.
- The Sezaby product label carries a Boxed Warning for the risks from concomitant use with opioids; dependence and withdrawal reactions after use of Sezaby for a longer duration than recommended; abuse, misuse, and addiction; and unapproved use in adolescents and adults.
- Common adverse reactions include abnormal respiration, sedation, feeding disorder, and hypotension.
Development timeline for Sezaby
|Nov 18, 2022
|Approval FDA Approves Sezaby (phenobarbital sodium powder for injection) for the Treatment of Neonatal Seizures
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