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🏅 FDA Orphan Designation

Sezaby

phenobarbital sodium

Manufacturer: Sun Pharmaceutical Industries, Inc.

Indicated for:
Self-limited neonatal epilepsyOrphan
⚠️

Black Box Warning (Boxed Warning)

A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.

View full prescribing information on DailyMed (NLM) ↗

FDA-Approved Indications (1)

treatment of neonatal seizures in term and preterm infants

Indications & Usage

1 INDICATIONS AND USAGE SEZABY is indicated for the treatment of neonatal seizures in term and preterm infants. SEZABY is a barbiturate indicated for the treatment of neonatal seizures in term and preterm infants.

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Sezaby
Sun Pharmaceutical Industries, Inc.

Where shown, WAC (Wholesale Acquisition Cost) is an estimate only — your actual cost depends on your insurance plan. Always verify pricing with your pharmacy or insurer.

Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.