BIRCH TRITERPENES | N215064 | CHIESI FARMACEUTICI SPA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lassman Law and Policy FDA-2023-P-4918 · 4 docket documents Scott M. Lassman filed this citizen petition on behalf of a client pursuant to 21 U.S.C. § 355, requesting that FDA refuse to approve Amryt Pharma plc's New Drug Application for Oleogel-S10 (FILSUVEZ) for treating cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa unless the | 505(q) | 2023-11-07 | Denied | Lassman Law and Policy |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| NCE | Dec 18, 2028 | Active |
| ODE-460 | Dec 18, 2030 | Active |