Sun Pharma Advanced Research Company (SPARC) announced that the U.S. District Court for the District of Columbia has granted summary judgment in favour of the company in the matter concerning the issuance of a Priority Review Voucher (PRV) associated with the approval of Sezaby.
The Court granted SPARC’s motion for summary judgment and stated 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”. The Court has allowed 60 days to appeal against the motion.
SPARC CEO, Anil Raghavan, said; “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.”