Sun Pharmaceutical Industries Limited today announced the launch of 'Sezaby' (phenobarbital sodium) in the U.S. for the treatment of neonatal seizures, via an exchange filing.
Sezaby is the first and only product approved by the U.S. Food and Drug Administration (USFDA) for the treatment of neonatal seizures in term and preterm infants.
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 US FDA for the treatment of neonatal seizures. “The launch of 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 FDA-approved product for the treatment of seizures in term and preterm infants, Sezaby has the potential to make a meaningful difference in the lives of patients and their families, and we are proud to be able to provide physicians with this new treatment option.”
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