In a regulatory filing made during market hours today, the company stated that the U.S. District Court for the District of Columbia 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.
Anil Raghavan, CEO, SPARC, 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.”
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.
Sun Pharma Advanced Research Company is a clinical stage bio-pharmaceutical company focused on continuously improving standards of care for patients globally, through innovation in therapeutics and delivery.
The company had reported a consolidated net loss of Rs 75.85 crore in the quarter ended September 2025 as against net loss of Rs 107.33 crore during the previous quarter ended September 2024. Sales declined 38.88% to Rs 7.86 crore in Q2 FY26 over Q2 FY25.