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( As on 02/12/2025 13:17)

SPARC wins U.S. Court Ruling on Priority Review Voucher for Sezaby

Sun Pharma Advanced Research Company Ltd (SPARC) announced that the U.S. District Court for the District of Columbia has granted summary judgment in its favour regarding the issuance of a Priority Review Voucher (PRV) linked to the approval of Sezaby.

The court ruled that the U.S. FDA’s decision to withhold the PRV was unlawful, stating that “no drug product containing phenobarbital sodium was ‘previously approved’ as that term is used in the statute.” The ruling allows a 60-day window for appeal.

Commenting on the development, SPARC CEO Anil Raghavan said the decision reaffirms the company’s long-standing position on the matter.