Treats migraine with or without aura. NDA 213436, held by Impel Pharms. Dihydroergotamine Mesylate.
As of Nov 13, 2026, NDA 213436 (Trudhesa), held by Impel Pharms, was first approved by FDA on Sep 2, 2021, with 0 approved supplements and 0 published complete response letters.
TRUDHESA is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use TRUDHESA is not indicated for the preventive treatment of migraine. TRUDHESA is not indicated for the management of hemiplegic or basilar migraine.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 2, 2021 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trudhesa0.725MG/SPRAY · spray, metered;nasal | Dihydroergotamine Mesylate | 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
