#SunPharma & Sun Pharma Advanced Research today announced that the U.S. Food & Drug Administration (US FDA) has approved SEZABY™ (phenobarbital sodium powder for injection) for the treatment of neonatal seizures.
With this approval, SEZABY becomes the first & only product specifically indicated in the U.S. for the treatment of neonatal seizures in term and preterm infants. SEZABY is expected to be available in the U.S. in Q4FY23.
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.
SEZABY was approved based on the results of NEOLEV2, a phase 2 study that evaluated levetiracetam compared to phenobarbital in the first-line treatment of neonatal seizures.
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