Relieves discomfort associated with acute, painful musculoskeletal conditions. NDA 219843, held by Rosemont Pharms. Methocarbamol.
As of Nov 13, 2026, NDA 219843 (Atmeksi), held by Rosemont Pharms, was first approved by FDA on Jul 30, 2025, with 0 approved supplements and 0 published complete response letters.
ATMEKSI (methocarbamol) oral suspension is a muscle relaxant indicated as: an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in patients 16 and older. 1.1 Acute, painful musculoskeletal conditions. ATMEKSI is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in patients 16 and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 30, 2025 | Original application | Approved |
| Atmeksi750MG/5ML · suspension;oral | Methocarbamol | RxReference drug |
| Atmeksi750MG(5ML) · suspension;oral | Methocarbamol | Rx |
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
