Treats intermittent, stereotypic episodes of frequent seizure activity. ANDA 217468, held by Navinta LLC. Diazepam.
As of Nov 13, 2026, ANDA 217468 (Diazepam), held by Navinta LLC, was first approved by FDA on Nov 14, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Diazepam rectal gel is intended 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 |
|---|---|---|---|
| Nov 14, 2025 | Original application | Approved |
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
