Treats fibromyalgia. NDA 219428, held by Tonix. Cyclobenzaprine Hydrochloride.
As of Nov 13, 2026, NDA 219428 (Tonmya), held by Tonix, was first approved by FDA on Aug 15, 2025, with 0 approved supplements and 0 published complete response letters.
TONMYA is indicated for treatment of fibromyalgia in adults. TONMYA is indicated for the treatment of fibromyalgia in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 15, 2025 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tonmya2.8MG · tablet;sublingual | Cyclobenzaprine Hydrochloride | RxReference drug |
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
