DESMOPRESSIN ACETATE | N022517 | FERRING PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Ferring Pharmaceuticals Inc. et al v. Serenity Pharmaceuticals, LLC et al 9 patentsdesmopressin | S.D.N.Y. | 2017-12-20 | Terminated 2020-08-21 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Avadel Specialty Pharmaceuticals, LLC FDA-2018-P-1949 · 45 docket documents Avadel Specialty Pharmaceuticals, LLC filed this citizen petition pursuant to Section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refrain from approving Ferring Pharmaceuticals' new drug application NDA 022517 for desmopressin acetate (Nocdurna) for treatment of noctur | 505(q) | 2018-05-21 | Denied | Avadel Specialty Pharmaceuticals, LLC |
Citizen Petition from Serenity Pharmaceuticals, LLC. FDA-2018-P-1760 · 5 docket documents Serenity Pharmaceuticals, LLC filed this citizen petition pursuant to Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA deny approval of Ferring's NDA 22-517 for Nocdurna (desmopressin) 25 and 50 micrograms sublingual tablets for treatment of nocturia, arguing that F | 505(q) | 2018-05-07 | Denied | Serenity Pharmaceuticals, LLC. |
Source: Regulations.gov. FDA citizen petitions matched by application number.