BRIEF—Sun Pharma launches Sezaby in USA; first FDA-approved product for neonatal seizures

Indian drugmaker Sun Pharmaceutical Industries today announced the launch of Sezaby (phenobarbital sodium) in the USA for the treatment of neonatal seizures.

Sezaby is the first and only product approved by the US Food and Drug Administration (US FDA) for the treatment of neonatal seizures in term and preterm infants.

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 in November last year.

“The launch of Sezaby is an exciting addition to our growing portfolio of specialty branded products in the US,” said Abhay Gandhi, chief executive North America, Sun Pharma, adding: “As the first and only FDA-approved product for the treatment of seizures in term and preterm infants, Sezaby has the potential to make a meaningful difference in the lives of patients and their families.”