Treats migraine with or without aura. NDA 21926, held by Azurity. Naproxen Sodium; Sumatriptan Succinate.
As of Nov 15, 2026, NDA 21926 (Treximet), held by Azurity, was first approved by FDA on Apr 15, 2008, with 12 approved supplements and 0 published complete response letters.
TREXIMET is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.
| May 14, 2015 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Apr 15, 2008 | Original applicationNew combination · Standard review | Approved |
| Treximet500MG;EQ 85MG BASE · tablet;oral | Naproxen Sodium; Sumatriptan Succinate | RxReference drug |
| Treximet60MG;EQ 10MG BASE · tablet;oral | Naproxen Sodium; Sumatriptan Succinate | DiscontinuedReference drug |
| Nov 21, 2024 | Supplement 19Labeling · Standard review | Approved | |
| Apr 28, 2021 | Supplement 18Labeling · Standard review | Approved | |
| Apr 28, 2021 | Supplement 17Labeling · Standard review | Approved | |
| Jul 22, 2019 | Supplement 16Labeling · Standard review | Approved | |
| May 9, 2016 | Supplement 13Labeling | Approved | |
| May 14, 2015 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| May 14, 2015 | Supplement 11Labeling · Standard review | Approved | |
| May 13, 2014 | Supplement 10Manufacturing · Standard review | Approved | |
| Mar 1, 2012 | Supplement 5Labeling | Approved | |
| Nov 14, 2011 | Supplement 2Labeling · Standard review | Approved | |
| Sep 23, 2011 | Supplement 6Labeling | Approved | |
| Oct 17, 2008 | Supplement 1Manufacturing · Standard review | Approved | |
| Apr 15, 2008 | Original applicationNew combination · Standard 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
