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SPARC: U.S. Court Grants Summary Judgement for Sezaby PRV

Sun Pharma Advanced Research Company (SPARC) announced that the U.S. District Court granted summary judgment in favor of SPARC regarding the Priority Review Voucher (PRV) associated with Sezaby. The court held that the FDA's withholding of the PRV was contrary to law. The court stated that no drug product containing phenobarbital sodium was 'previously approved' as defined in the statute. There is a 60-day window for appeals against the motion.