SPARC rises on USFDA approval for Sezaby

18 Nov 2022 , 10:21 AM

With this approval by U.S. Food and Drug Administration (USFDA), Sezaby became 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 Q4 FY23. 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 USFDA for the treatment of neonatal seizures. Sezaby was recently licensed by SPARC to Sun Pharma. The company said that under the terms of the license agreement, it is eligible to receive a milestone payment on approval of Sezaby by the USFDA. Abhay Gandhi, CEO North America, Sun Pharma said, ?Sezaby is an exciting addition to our growing portfolio of specialty branded products in the U.S. 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.? Anil Raghavan, CEO of SPARC said, ?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 USFDA.? The pharma company said that 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. Sun Pharma Advanced Research Company (SPARC) is a pharmaceutical company focused on continuously improving standards of care for patients globally through innovation in therapeutics and delivery. The companys standalone net loss during Q2 FY23 was Rs 68.40 crore as compared to a net loss of Rs 55.14 crore in Q2 FY22. Standalone revenue from operations rose 13.2% YoY to Rs 31.54 crore in the quarter ended 30 September 2022. Powered by Capital Market – Live News