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Sun Pharma, SPARC gets USFDA nod for neonatal seizures treatment product

Sun Pharma, SPARC gets USFDA nod for neonatal seizures treatment product

Sun Pharma, SPARC gets USFDA nod for neonatal seizures treatment product
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By CNBCTV18.com Nov 19, 2022 8:47:07 AM IST (Published)

SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection and it was recently licenced by SPARC to Sun Pharma.

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Sun Pharma on Friday said that it has received approval from the United States Food and Drug Administration (USFDA) for SEZABY, phenobarbital sodium powder for injection, used for the treatment of neonatal seizures.
With this approval, SEZABY becomes the first and only product specifically indicated in the US, used in the treatment of neonatal seizures in term and pre-term infants.
SEZABY will be available in the US markets from the March quarter of the current financial year.
The product is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection and it was recently licensed by SPARC to Sun Pharma. As per the terms of the agreement, SPARC will be receiving a milestone payment on approval of SEZABY by the USFDA.
Sun Pharma believes that the product will add to its growing specialty products portfolio in the US.
The incidence of seizures during the first month of life is about 1 to 4 per 1,000 babies. 1 The occurrence is associated with poor outcomes such as cerebral palsy and global developmental delay.
Shares of Sun Pharma ended 0.45 percent lower at Rs 1,008, while those of SPARC ended 2.7 percent higher at Rs 246.15.
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