Sezaby is approved by the FDA for the treatment of neonatal seizures .- Sun Pharma
Sun Pharmaceutical Industries Limited and Sun Pharma Advanced Research Company Ltd. announced that the FDA 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.
Sezaby was granted orphan drug designation by the FDA for the treatment of neonatal seizures.
“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, Sezalby 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 FDA,” said Anil Raghavan, CEO, SPARC. Sezaby was approved based on the results of NEOLEV2, a phase II study that evaluated levetiracetam compared to phenobarbital in the first-line treatment of neonatal seizures.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
2 mins