US District Court grants summary judgement in favour of SPARC for Sezaby PRV

Mumbai: Sun Pharma Advanced Research Company has announced that the U.S. District Court for the District of Columbia has granted summary judgment in favour of SPARC in the matter of issuance of Priority Review Voucher (PRV) associated with the approval of Sezaby.

The Court 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.

“We are pleased with the ruling issued today by the U.S. District Court, as it validates SPARC’s long held position on this matter” said SPARC CEO, Anil Raghavan.

SEZABY is a benzyl alcohol and propylene glycol free formulation of phenobarbital sodium powder for injection. It was approved by the US FDA for the treatment of neonatal seizures.

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