New Drug Application Nda And Supplemental Nda Snda Requirements Cases

Vanda Pharmaceuticals, Inc. v. FDA

D.C. Circuit Vacates FDA Denial of Citizen Petition on Generic Drug Approval

Vanda Pharmaceuticals, Inc. v. FDA, decided by D.C. Circuit on August 15, 2025, resulted in a remanded outcome. The D.C. Circuit reviewed the FDA's denial of Vanda Pharmaceuticals' citizen petition se...