Treats bipolar I disorder. NDA 218879, held by Owp Pharms. Lamotrigine.
As of Nov 13, 2026, NDA 218879 (Subvenite), held by Owp Pharms, was first approved by FDA on Sep 16, 2025, with 2 approved supplements and 1 published complete response letter.
SUBVENITE is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: partial-onset seizures primary generalized tonic-clonic (PGTC) seizures generalized seizures of Lennox-Gastaut syndrome. Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 16, 2025 | Original applicationNew dosage form · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jan 3, 2025 | NDA 218879Product Quality, Facility Inspections | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Subvenite10MG/ML · suspension;oral | Lamotrigine | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 17, 2026 | Supplement 2Labeling · Standard review | Approved | |
| Jul 17, 2026 | Supplement 1Labeling · Standard review | Approved | |
| Sep 16, 2025 | 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
