BRIEF—FDA approves Sun Pharma's Sezaby

India’s Sun Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has approved Sezaby (phenobarbital sodium powder for injection) for the treatment of neonatal seizures.

With this approval, Sezaby becomes the first and only product specifically indicated in the USA for the treatment of neonatal seizures in term and preterm infants, and is expected to be available in the USA in fourth-quarter fiscal year 2023.

Sezaby is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection. It was granted orphan drug designation by the US FDA for the treatment of neonatal seizures.

Sezaby was recently licensed by SPARC to Sun Pharma.

Under the terms of the license agreement, SPARC is eligible to receive a milestone payment on approval of Sezaby by the US FDA.