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Systematix Research Report
Sun Pharma Advanced Research Company has received U.S. Food and Drug Administration approval for Sezaby (phenobarbital sodium) for the treatment of neonatal seizures.
The drug is the first and only product approved for treating seizures in neonatal patients. The product is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection.
It was granted an orphan drug designation by the U.S. FDA for the treatment of neonatal seizures and would receive seven years exclusivity.
Sun Pharmaceutical Industries Ltd. which has commercial marketing rights, expects to launch Sezaby in the U.S. in Q4 FY23. We believe this can be a $60-100 million peak sales opportunity for SPARC/Sun Pharma.
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