India Pharma Outlook Team | Wednesday, 04 February 2026
Sun Pharma Advanced Research Company Ltd. (SPARC) announced that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Priority Review Voucher (PRV) linked to its neonatal seizure therapy Sezaby, marking a major regulatory milestone for the company.
Previous approvals were made of Sezaby, a benzyl alcohol/propylene glycol-free phenobarbital sodium powder to treat the neonatal seizure in infants, but SPARC did not obtain the associated PRV.
The firm appealed to the court of FDA and last month, the U.S district court of the District of Columbia ruled in favor of SPARC stating that the FDA had acted unreasonably by refusing to issue the voucher earlier.
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In a statement, SPARC CEO Anil Raghavan said, “Receiving this Priority Review Voucher is a significant milestone for SPARC and a testament to our commitment to addressing the urgent, unmet needs of patients.” He added that the award gives the company “additional strategic flexibility to accelerate our pipeline development to bring more therapies to patients faster.”
Priority Review Voucher is a marketable regulatory asset created by FDA to compensate the development of treatments of rare diseases among the pediatrics. It can be redeemed to guarantee a quicker review on another upcoming application of the drug. That is why SPARC can use it to accelerate the approval of a drug that is critical or sell it to raise funds to support its research pipeline.
It is viewed as an advantage to the innovation strategy of SPARC because it provides it with a useful instrument in its quest to develop new therapies and increase its global presence in the treatment of rare diseases.
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