Treats migraine with or without aura. NDA 215431, held by Axsome. Meloxicam; Rizatriptan Benzoate.
As of Nov 13, 2026, NDA 215431 (Symbravo), held by Axsome, was first approved by FDA on Jan 30, 2025, with 0 approved supplements and 0 published complete response letters.
SYMBRAVO is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use SYMBRAVO should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with SYMBRAVO, the diagnosis of migraine should be reconsidered before SYMBRAVO is administered to treat any subsequent attacks. SYMBRAVO is not indicated for the preventive treatment of migraine attacks. SYMBRAVO is not indicated for the treatment of cluster headache.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 30, 2025 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Symbravo20MG;EQ 10MG BASE · tablet;oral | Meloxicam; Rizatriptan Benzoate | 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
