Treats moderate to severe acute pain, including postoperative pain. NDA 219209, held by Vertex Pharms Inc. Suzetrigine.
As of Nov 14, 2026, NDA 219209 (Journavx), held by Vertex Pharms Inc, was first approved by FDA on Jan 30, 2025, with 1 approved supplement and 0 published complete response letters.
JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 30, 2025 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Journavx50MG · tablet;oral | Suzetrigine | RxReference drug |
| Jan 23, 2026 | Supplement 9Labeling · Standard review | Approved | |
| Jan 30, 2025 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
