SUZETRIGINE | N219209 | VERTEX PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Kaylin Bower FDA-2025-P-1955 · 3 docket documents Kaylin Bower filed this citizen petition requesting that the FDA amend the labeling for Journavx (suzetrigine) to include a "Limitation of Use" statement in the Indications and Usage section, arguing that clinical trial data from the bunionectomy study showed the median time to first rescue analgesi | 505(q) | 2025-06-26 | Open | Kaylin Bower |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$15.41
per ea
Lowest NADAC/Unit
$15.41
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 51167054830JOURNAVX 50 MG TABLET | $15.41 | EA | Brand | — | 2026-07-01 |
| 51167054831JOURNAVX 50 MG TABLET | $15.41 | EA | Brand | — | 2026-07-01 |
| 51167054834JOURNAVX 50 MG TABLET | $15.41 | EA | Brand | — | 2026-07-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 11834441 | Dec 4, 2040 | — | Yes | Yes | — |
| Code | Date | Status |
|---|---|---|
| NCE | Jan 30, 2030 | Active |