SPARC wins US court ruling for Sezaby PRV

Sun Pharma Advanced Research Company (SPARC) today confirmed that the U.S. District Court for the District of Columbia granted summary judgment in its favor concerning the issuance of a Priority Review Voucher (PRV) linked to the approval of Sezaby. The court determined that the FDA’s withholding of the PRV was unlawful, stating that no phenobarbital sodium drug product had been "previously approved" as defined by statute.

The ruling allows 60 days for an appeal against the motion. SPARC chief executive Anil Raghavan expressed satisfaction with the court's decision, affirming that it validates the company’s long-held position on the matter. Sezaby, a benzyl alcohol and propylene glycol-free phenobarbital sodium powder for injection, received US FDA approval for treating neonatal seizures.