Treats migraine with or without aura. NDA 210884, held by Tonix Meds. Sumatriptan.
As of Nov 13, 2026, NDA 210884 (Tosymra), held by Tonix Meds, was first approved by FDA on Jan 25, 2019, with 0 approved supplements and 0 published complete response letters.
TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 2019 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tosymra10MG/SPRAY · spray;nasal | Sumatriptan | 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
