Sun Pharma gains FDA OK for Sezaby

Sun Pharma and Sun Pharma Advanced Research obtained the Food and Drug Administration’s nod for Sezaby (phenobarbital sodium powder for injection) for the treatment of neonatal seizures.

Sezaby is the first and only product specifically indicated for the treatment of neonatal seizures in term and preterm infants, the company said.

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

“Sezaby is an exciting addition to our growing portfolio of specialty branded products in the United States,” said Abhay Gandhi, CEO North America of 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.”

“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, of SPARC.

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Sezaby is expected to be available in Q4 FY23, according to the company.