US District Court grants summary judgement in favour of SPARC for Sezaby PRV
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-12-02 09:12 GMT | Update On 2025-12-02 09:12 GMT
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Mumbai: Sun Pharma Advanced Research Company has announced that the U.S. District Court for the District of Columbia has granted summary judgment in favour of SPARC in the matter of issuance of Priority Review Voucher (PRV) associated with the approval of Sezaby.
The Court granted SPARC’s motion for summary judgment and held that “FDA’s withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was ‘previously approved’ as that term is used in the statute” and allowed 60 days to appeal against the motion.
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