Sun Pharmaceutical Industries on Friday said the U.S. Food and Drug Administration has approved Sezaby (phenobarbital sodium powder for injection) for the treatment of neonatal seizures.
A benzyl alcohol-free and propylene glycol-free formulation, it was granted orphan drug designation by the regulator for treatment of neonatal seizures. With the approval, it becomes the first and only product specifically indicated in the U.S. for treatment of neonatal seizures in term and preterm infants. The product is expected to be available, in the U.S., in the fourth quarter of FY23.
Sun Pharma Advanced Research Company had licensed Sezaby recently to Sun Pharma and under the agreement, SPARC is eligible to receive a milestone payment on U.S. FDA approval. “It is an exciting addition to our growing portfolio of specialty branded products in the U.S.,” said Abhay Gandhi, CEO North America, Sun Pharma.
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. “For years, physicians have had limited treatment options to manage neonates with seizures. SPARC is proud to have developed benzyl alcohol-free and propylene glycol-free phenobarbital sodium powder for injection as the first treatment option now approved by the U.S. FDA,” said Anil Raghavan, CEO of SPARC.
