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# Judge Strikes Down FDA Decision Blocking Priority Voucher
- URL: https://www.fdaweb.com/judge-strikes-down-fda-decision-blocking-priority-voucher/
- Published: 2025-12-02T12:00:00.000Z
- Updated: 2026-09-14T15:28:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160304

A Washington, DC, federal judge has ruled that FDA acted unlawfully when it denied a priority review voucher to Sun Pharma and its drug Sezaby (phenobarbital sodium), the first FDA-approved treatment specifically shown to be effective for neonatal seizures. The decision criticized the agency’s reliance on a long-withdrawn, decades-old drug application to justify its refusal.

In the 13-page [opinion](https://ecf.dcd.uscourts.gov/cgi-bin/show%5Fpublic%5Fdoc?2024cv0946-38&ref=fdaweb.com), U.S. district judge **Amit P. Mehta** granted summary judgment to plaintiffs Sun Pharma and its affiliate, finding FDA improperly concluded that Sezaby’s active moiety, phenobarbital, had been “previously approved” under federal law. That determination disqualified the company from receiving a rare pediatric disease priority review voucher, a financial incentive Congress created to spur development of treatments for serious childhood conditions.

According to the opinion, at issue was whether an application for a phenobarbital–atropine combination product filed in 1939 was the first phenobarbital product approved when it was technically grandfathered into use. The drug remained on the market for decades until the agency concluded in the 1970s that there was no substantial evidence it worked. After the sponsor abandoned the product, FDA formally withdrew the application in 1982.

The agency nevertheless argued that because the drug was once “deemed approved” under transitional provisions of the 1962 Drug Amendments, Sezaby’s active moiety had been “previously approved,” barring Sun Pharma from obtaining a voucher. But judge Mehta rejected that view, calling it inconsistent with both the text and purpose of the rare pediatric disease statute. Approval under the Federal Food, Drug, and Cosmetic Act, he wrote, has a “precise and undisputed meaning”— a formal, affirmative decision by the agency after reviewing evidence of safety and effectiveness. A product that was only deemed approved by statute, and later withdrawn for lack of efficacy, does not meet that standard, he said.

“A thing that is deemed to be something else does not become that something else,” Mehta wrote, emphasizing that Congress never intended the 1962 temporary transition category to block modern incentives for new treatments.

The court also noted that Sezaby is the first phenobarbital product ever to establish efficacy for neonatal seizures. Allowing a never-proven 1939 product to disqualify the drug, the judge said, would contradict Congress’s goal of encouraging innovation for rare pediatric diseases.

The ruling sets aside the FDA’s denial of the voucher, clearing the way for Sun Pharma to receive the potentially lucrative award. The voucher can be sold or used to obtain a faster FDA review for another drug product.

FDA and the Justice Department have not yet indicated whether they will appeal the opinion.