SPARC receives FDA Rare Pediatric Disease PRV after Sezaby® approval for neonatal seizures. Learn how this voucher accelerates their pipeline for urgent newborn treatments
Written By: Pharmacally Medical News Desk
Sun Pharma Advanced Research Company Ltd. (SPARC) has announced that it has received a Rare Pediatric Disease Priority Review Voucher (PRV) from the United States Food and Drug Administration (FDA). The voucher is associated with the FDA approval of Sezaby®, a treatment developed for neonatal seizures.
The company stated that it plans to utilize this strategic asset to accelerate the development of its broader pipeline.
Commenting on the milestone, Anil Raghavan, CEO of SPARC, said that receiving the voucher represents a major achievement for the company. He emphasized that the award reflects both the therapeutic value of Sezaby® and SPARC’s commitment to urgent patient needs.
He also noted that the PRV provides SPARC with additional flexibility to speed up the advancement of its pipeline, enabling faster access to innovative treatments.
About Sezaby®
Sezaby® is a phenobarbital sodium powder for injection that is free from benzyl alcohol and propylene glycol. The FDA approved it specifically for the treatment of neonatal seizures, an area where safer and specialized formulations are critical for newborn patients.
The approval and subsequent voucher reinforce the importance of advancing therapies designed for vulnerable pediatric populations.
About SPARC
SPARC is an innovation-driven pharmaceutical company. It develops novel therapeutics and drug delivery solutions to raise global care standards, improve affordability, and boost accessibility while maintaining efficiency.
Understanding the Priority Review Voucher Program
The FDA’s Priority Review Voucher program incentivizes therapies for rare pediatric diseases. These tradable vouchers let companies secure priority review for a future, unrelated drug application slashing timelines and hastening patient access to new treatments.
References
SPARC Announces Receipt of Priority Review Voucher associated with Sezaby® Approval, 03 February 2026, https://sparc.life/wp-content/uploads/2026/02/Press-Release_Sezaby-PRV-appeal_3rd-Feb.pdf