Sun Pharmaceutical Industries on Friday said it has received an approval from the US health regulator for SEZABY, a formulation used for treatment of neonatal seizures.
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 Food and Drug Administration (USFDA) for the treatment of neonatal seizures, Sun Pharma said in a regulatory filing.
Orphan drug designation is granted by the USFDA to a medicine intended to treat a condition affecting fewer than 2 lakh persons in the US, or which will not be profitable within seven years following its approval.
"With this approval, SEZABY becomes the first and only product specifically indicated in the US for the treatment of neonatal seizures in term and pre-term infants," the company said.
The drug is expected to be available in the US in the fourth quarter of FY23, it added.
Sun Pharma Advanced Research Company Ltd (SPARC) had recently licensed SEZABY to Sun Pharma, under which SPARC is eligible to receive a milestone payment on approval of SEZABY by the USFDA, the filing added.
"As the first and only product specifically indicated to treat seizures in term and pre-term infants, SEZABY has the potential to make a difference in the lives of patients and their families," Sun Pharma CEO North America Abhay Gandhi said.
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