Sun Pharma Advanced Research Company (SPARC) has been granted a Rare Pediatric Disease Priority Review Voucher (PRV) by the FDA following the approval of Sezaby®. The voucher underscores SPARC’s commitment to addressing unmet medical needs and may be used to accelerate its pipeline. SPARC intends to utilize the voucher to further accelerate its pipeline.
FDA Grants Priority Review Voucher
Sun Pharma Advanced Research Company Ltd. (SPARC) announced on February 3, 2026, that the United States Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Priority Review Voucher (PRV) associated with the approval of Sezaby®.
Purpose of the Voucher
A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases. It can be redeemed to receive priority review for a subsequent, separate drug application.
Strategic Implications for SPARC
According to Anil Raghavan, CEO of SPARC, receiving this Priority Review Voucher is a significant milestone and demonstrates their commitment to addressing unmet needs. The award recognizes the therapeutic value of Sezaby® and provides SPARC with additional strategic flexibility to accelerate their pipeline development.
About Sezaby®
SEZABY® is a benzyl alcohol and propylene glycol-free formulation of phenobarbital sodium powder for injection and is approved for the treatment of neonatal seizures.
Source: BSE
