SPARC announces receipt of priority review voucher associated with Sezaby approval
A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases
A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases
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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