Sun Pharma receives USFDA approval for SEZABY

25 Nov 2022 , 01:35 AM

nbsp;Sun Pharmaceuticals Industries today announced that the US Food and 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 and only product specifically indicated in the US for the treatment of neonatal seizures in term and preterm infants

SEZABY is expected to be available in the US 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