Treats migraine with or without aura. NDA 211280, held by Eli Lilly And Co. Lasmiditan Succinate.
As of Nov 14, 2026, NDA 211280 (Reyvow), held by Eli Lilly And Co, was first approved by FDA on Oct 11, 2019, with 5 approved supplements and 0 published complete response letters.
REYVOW is indicated for the acute treatment of migraine with or without aura in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 11, 2019 | Original applicationNew molecular entity · Standard review | Approved |
| ReyvowEQ 50MG BASE · tablet;oral | Lasmiditan Succinate | DiscontinuedReference drug |
| ReyvowEQ 100MG BASE · tablet;oral | Lasmiditan Succinate | DiscontinuedReference drug |
| ReyvowEQ 200MG BASE · tablet;oral | Lasmiditan Succinate | DiscontinuedReference drug |
| Sep 15, 2022 | Supplement 8Labeling · Standard review | Approved | |
| Jul 15, 2022 | Supplement 7Labeling · Standard review | Approved | |
| Jan 25, 2022 | Supplement 6Manufacturing | Approved | |
| Jun 3, 2021 | Supplement 5Labeling · Standard review | Approved | |
| Jul 17, 2020 | Supplement 1Labeling · Standard review | Approved | |
| Oct 11, 2019 | Original applicationNew molecular entity · Standard review | Approved |
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
