US District Court grants summary judgement in Favour of SPARC for Sezaby PRV
FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved'
FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved'
SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection
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