Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
FENFLURAMINE | A216108 | APOTEX INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2021-10-28 | Terminated 2023-11-28 | — | |
| D. Del. | 2021-08-30 | Terminated 2023-11-28 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from UCB, Inc. FDA-2023-P-1984 · 14 docket documents UCB, Inc. filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to approve Apotex Inc.'s ANDA 216108 for fenfluramine hydrochloride oral solution unless the labeling includes information about concomitant administration with stiripen | 505(q) | 2023-05-17 | Denied | UCB, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.