Sun Pharma gets USFDA nod for neonatal seizures treatment SEZABY

Mumbai: Sun Pharmaceutical Industries Limited and Sun Pharma Advanced Research Company Ltd. today announced that the U.S. Food and Drug Administration (USFDA) 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 U.S. for the treatment of neonatal seizures in term and preterm infants. SEZABY is expected to be available in the U.S. in Q4FY23," the release stated.

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

Read also: SPARC investigational drug shows promise in phase 3 trial for treating inflammation, pain related to ocular surgery

It was granted orphan drug designation by the USFDA 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 USFDA.

"SEZABY is an exciting addition to our growing portfolio of specialty branded products in the U.S.," said Abhay Gandhi, CEO North America, Sun Pharma. "As the first and only product specifically indicated to treat seizures in term and preterm infants, SEZABY has the potential to make a difference in the lives of patients and their families."

Read also: SPARC licenses PDP-716, SDN-037 drug rights to Visiox Pharma

"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 US FDA," said Anil Raghavan, CEO, SPARC.

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.

Read also: Sun Pharma, SPARC collaborate for commercialization of phenobarbital for injection in US