Treats intermittent, stereotypic episodes of frequent seizure activity. NDA 211635, held by Neurelis Inc. Diazepam.
As of Nov 13, 2026, NDA 211635 (Valtoco), held by Neurelis Inc, was first approved by FDA on Jan 10, 2020, with 5 approved supplements and 0 published complete response letters.
VALTOCO is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2025 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jan 10, 2020 | Original applicationNew dosage form · Standard review | Approved |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 14, 2025 | Supplement 12Manufacturing | Approved | |
| Apr 15, 2025 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jan 13, 2023 | Supplement 8Labeling · Standard review | Approved | |
| Feb 4, 2022 | Supplement 7Labeling · Standard review | Approved | |
| Feb 5, 2021 | Supplement 3Labeling · Standard review | Approved | |
| Jan 10, 2020 | Original applicationNew dosage form · 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
