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# Appeals Court Backs FDA’s Sameness Interpretation
- URL: https://www.fdaweb.com/appeals-court-backs-fdas-sameness-interpretation/
- Published: 2025-06-27T12:00:00.000Z
- Updated: 2026-09-14T15:15:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159432

The U.S. Court of Appeals for the D.C. Circuit has upheld a lower court’s decision for FDA that a “clinically superior drug is not the same as a drug that is otherwise the same.” The appeals [court reaffirmed](https://media.cadc.uscourts.gov/opinions/docs/2025/06/24-5262-2122600.pdf?ref=fdaweb.com) that FDA acted correctly in determining that Avadel CNS Pharmaceuticals’ Lumryz (sodium oxybate) is a different drug than Jazz Pharmaceuticals’ Xywav (sodium oxybate) because of a different dosing regimen, and thus correctly approved the Avadel product for marketing before Xywav finished its orphan drug marketing exclusivity.

Jazz had argued that FDA incorrectly concluded that Lumryz and Xywav are not the same drug, even though they have the same active moiety, but not the same dosing regimen. It also contended that the agency’s determination that Lumryz was clinically superior to Xywav was arbitrary and capricious because it did not comply with internal dispute resolution procedures and because the findings were inconsistent with the scientific literature.

In agreeing with the lower court’s decision, the appeals court supported FDA’s finding that Lumryz’s extended-release formulation demonstrated a clinical superiority because it is a major improvement in patient convenience — eliminating a middle-of-the-night dose, and justifying its separate exclusivity period.