TAFAMIDIS | N212161 | FOLDRX PHARMACEUTICALS LLC A WHOLLY OWNED SUB OF PFIZER INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2025-12-18 | Active | — | |
| D. Del. | 2025-10-24 | Active | — | |
| D. Del. | 2023-08-18 | Active | — | |
Pfizer Inc. et al v. Dexcel Pharma Technologies Limited, et al 3 patentsANDA 218365tafamidis | D. Del. | 2023-08-10 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services, Inc. FDA-2025-P-2170 Lachman Consulting Services, Inc., on behalf of a client, filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to declare Tafamidis Tablets, 61 mg suitable for submission as an Abbreviated New Drug Application based on the refere | Suitability | 2025-07-07 | Open | Lachman Consulting Services |
Source: Regulations.gov. FDA citizen petitions matched by application number.