Relieves discomforts associated with acute, painful musculoskeletal conditions. NDA 22503, held by Primus Pharms. Metaxalone.
As of Nov 13, 2026, NDA 22503 (Metaxalone), held by Primus Pharms, was first approved by FDA on Jun 1, 2015, with 3 approved supplements and 0 published complete response letters.
Metaxalone Tablets, 640 mg, are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 1, 2015 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Metaxalone640MG · tablet;oral | Metaxalone | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 8, 2025 | Supplement 4Labeling · Standard review | Approved | |
| Jan 10, 2024 | Supplement 3Labeling · Standard review | Approved | |
| Feb 25, 2022 | Supplement 1Labeling · Standard review | Approved | |
| Jun 1, 2015 | 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
