GLASDEGIB MALEATE | N210656 | PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Avadel Specialty Pharmaceuticals, LLC FDA-2018-P-1949 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Pfizer's patent '8148401 for Daurismo (glasdegib maleate) was extended from Apr 2029 to Nov 2032 in the Orange Book.
Old: Apr 14, 2029
New: Nov 21, 2032
Patent 8,148,401 covering Daurismo (glasdegib maleate) extended its expiration date from Apr 2029 to Nov 2032.
Old: Apr 14, 2029
New: Nov 21, 2032