Sun Pharmaceutical launches phenobarbital sodium injection in US

Sun Pharmaceutical Industries Ltd on Wednesday launched its phenobarbital sodium injection, SEZABY for the 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.

It is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection.

Sun Pharma SEZABY was granted 'orphan drug' designation by the USFDA for the treatment of neonatal seizures.

Orphan drug designation is granted by the USFDA to medicine intended to treat a condition affecting fewer than 2 lakh persons in the US, or which will not be profitable within seven years following its approval.