SPARC Receives FDA's Rare Pediatric Disease Priority Review Voucher for Sezaby®
Sun Pharma Advanced Research Company has been granted the FDA's Rare Pediatric Disease Priority Review Voucher associated with Sezaby® approval. This tradable voucher can be used to accelerate future drug applications and represents recognition of Sezaby®'s therapeutic value in treating neonatal seizures with its specialized benzyl alcohol and propylene glycol free formulation.

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Sun Pharma Advanced Research Company Ltd. (SPARC) has received the United States Food and Drug Administration's (USFDA) Rare Pediatric Disease Priority Review Voucher (PRV) associated with the approval of Sezaby®. This milestone underscores the company's commitment to addressing high unmet medical needs and provides strategic flexibility for future pipeline acceleration.
Priority Review Voucher Details
The Priority Review Voucher represents a significant regulatory achievement for SPARC. The PRV is a tradable voucher granted by the FDA specifically to encourage the development of new treatments for rare pediatric diseases. This voucher can be redeemed to receive priority review for a subsequent, separate drug application, providing valuable strategic options for the pharmaceutical company.
| Parameter: | Details |
|---|---|
| Voucher Type: | Rare Pediatric Disease Priority Review Voucher |
| Associated Product: | Sezaby® |
| Granting Authority: | United States Food and Drug Administration |
| Strategic Use: | Pipeline acceleration for future applications |
Management Commentary
Anil Raghavan, CEO of SPARC, emphasized the significance of this achievement. "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 stated. "This award not only recognizes the therapeutic value of Sezaby® but also provides SPARC with additional strategic flexibility to accelerate our pipeline development to bring more therapies to patients faster."
About Sezaby®
Sezaby® represents an important therapeutic advancement in neonatal care. The product is a benzyl alcohol and propylene glycol free formulation of phenobarbital sodium powder for injection, specifically approved by the FDA for the treatment of neonatal seizures. This specialized formulation addresses critical safety considerations for vulnerable neonatal patients.
| Product Feature: | Description |
|---|---|
| Active Ingredient: | Phenobarbital sodium powder |
| Formulation: | Benzyl alcohol and propylene glycol free |
| Administration: | For injection |
| Indication: | Treatment of neonatal seizures |
| Regulatory Status: | FDA approved |
Company Profile
Sun Pharma Advanced Research Company Ltd. operates as a pharmaceutical company focused on continuously improving standards of care for patients globally through innovation in therapeutics and delivery. The company consistently aims to lower costs and improve operational efficiencies to advance availability and affordability of cures for patients across the world.
Historical Stock Returns for Sun Pharma Advanced Research Co
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +4.01% | +11.13% | +2.31% | -7.33% | -10.69% | -26.32% |
































