fdca-drug-definition
1 cases — ← All topics
| Case | Title | Lower Court | Docketed | Status | Flags | Tags | Question Presented |
|---|---|---|---|---|---|---|---|
| 24A1149 | Teva Branded Pharmaceutical Products R&D, Inc., et al. v. Amneal Pharmaceuticals of New York, LLC, et al. | Federal Circuit | 2025-05-27 | Presumed Complete | fdca-drug-definition generic-drug-approval hatch-waxman-amendments orange-book paragraph-iv-certification patent-listing | Whether the Federal Circuit properly interpreted the statutory definition of 'drug' under 21 U.S.C. § 321(g)(1)(D) and the Orange Book listing require… |