Defendant

U.S. Food and Drug Administration

1 case as defendant.

Cases
1
Active
0
1 closed
Filed
2022
Top venue
D. Columbia
1 case

Avadel CNS Pharmaceuticals, LLC v. Xavier Becerra et al.

denied Avadel's requested relief
Docket:
1:22-cv-02159
Filed:
2022-07-21
Patents:8731963
π Avadel CNS Pharmaceuticals, LLCΔ Xavier BecerraΔ Robert M. CaliffΔ U.S. Department of Health and Human ServicesΔ U.S. Food and Drug Administration

APA challenge to FDA's requirement that Avadel certify against U.S. 8,731,963 (REMS patent). Jazz Pharmaceuticals intervened on July 28, 2022, to defend the FDA decision. The D.D.C. denied Avadel's requested relief, holding Avadel had an adequate remedy at law via its delisting counterclaim in the Delaware action.