Sun Pharmaceutical Industries Ltd on Wednesday launched its phenobarbital sodium injection, SEZABY for treatment of neonatal seizures in the US. SEZABY is the first and only product approved by the US Food and Drug Administration (USFDA) for the treatment of neonatal seizures in term and preterm infants, Sun Pharma said in a regulatory filing.
Sun Pharmaceutical Industries on Friday said it has received an approval from the US health regulator for SEZABY, a formulation used for treatment of neonatal seizures. SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection.
Enforcement Report - Week of April 13, 2022