The US District Court for the district of Columbia granted SPARC's motion for summary judgment and held that "FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved' as that term is used in the statute" and allowed 60 days to appeal against the motion, the company said in an exchange filing.
The company's CEO Anil Raghavan said he was pleased with the ruling as it validates the company's long-held position on the matter.
Sezaby is a benzyl alcohol and propylene glycol free formulation of phenobarbital sodium powder for injection. The US Food and Drug Administration (USFFDA) had approved the same for the treatment of neonatal seizures.
SPARC shares were up 14.6% at 153.78 apiece around 12.40 pm. The stock has declined 23.4% this year, so far.
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