Treats migraine attacks with or without aura. NDA 22165, held by Cosette. Diclofenac Potassium.
As of Nov 13, 2026, NDA 22165 (Cambia), held by Cosette, was first approved by FDA on Jun 17, 2009, with 9 approved supplements and 0 published complete response letters.
Diclofenac Potassium is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use: Diclofenac Potassium is not indicated for the prophylactic therapy of migraine. The safety and effectiveness of Diclofenac Potassium have not been established for cluster headache, which is present in an older, predominantly male population.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 17, 2009 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cambia50MG · for solution;oral | Diclofenac Potassium | RxReference drug |
| Nov 21, 2024 | Supplement 16Labeling · Standard review | Approved | |
| Apr 23, 2024 | Supplement 6Labeling · Standard review | Approved | |
| Apr 28, 2021 | Supplement 14Labeling · Standard review | Approved | |
| Apr 28, 2021 | Supplement 13Labeling · Standard review | Approved | |
| Mar 20, 2017 | Supplement 12Labeling · Standard review | Approved | |
| May 9, 2016 | Supplement 11Labeling · Standard review | Approved | |
| Dec 10, 2015 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Sep 30, 2014 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 20, 2011 | Supplement 4REMS | Approved | |
| Jun 17, 2009 | Original applicationNew dosage form · 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
