Treats migraine with or without aura. ANDA 204841, held by Lannett Co Inc. Sumatriptan.
As of Nov 13, 2026, ANDA 204841 (Sumatriptan), held by Lannett Co Inc, was first approved by FDA on Feb 19, 2016, with 2 approved supplements and 0 published complete response letters.
Sumatriptan nasal spray, USP is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks. Sumatriptan is not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan nasal spray, USP have not been established for cluster headache.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 19, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sumatriptan5MG/SPRAY · spray;nasal | Sumatriptan | Rx |
| Sumatriptan20MG/SPRAY · spray;nasal | Sumatriptan | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 26, 2018 | Supplement 8Manufacturing | Approved | None posted |
| Jun 26, 2018 | Supplement 11Labeling · Standard review | Approved | None posted |
| Feb 19, 2016 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
