TAFAMIDIS MEGLUMINE | N211996 | FOLDRX PHARMACEUTICALS LLC A WHOLLY OWNED SUB OF PFIZER INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2023-08-23 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Axar Laboratories, Inc. FDA-2025-P-1104 Axar Laboratories, Inc. filed this citizen petition on April 17, 2025, challenging the patent term extension eligibility for VYNDAQEL (tafamidis meglumine, NDA 211996) by requesting that the FDA Commissioner determine the applicant (Scripps Research Institute, FoldRx Pharmaceuticals, LLC, and Pfizer | Other | 2025-04-22 | Denied | Axar Laboratories |
Source: Regulations.gov. FDA citizen petitions matched by application number.