Treats migraine with or without aura. ANDA 208967, held by Regcon Holdings. Sumatriptan.
As of Nov 13, 2026, ANDA 208967 (Sumatriptan), held by Regcon Holdings, was first approved by FDA on Feb 17, 2021, with 0 approved supplements and 0 published complete response letters.
Sumatriptan nasal spray 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 nasal spray, reconsider the diagnosis of migraine before Sumatriptan nasal spray is administered to treat any subsequent attacks. Sumatriptan is not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan nasal spray have not been established for cluster headache.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 17, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sumatriptan20MG/SPRAY · spray;nasal | Sumatriptan | Rx |
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
