Subvenite FDA Approval History
FDA Approved: Yes (First approved September 16, 2025)
Brand name: Subvenite
Generic name: lamotrigine
Dosage form: Oral Suspension
Company: OWP Pharmaceuticals, Inc.
Treatment for: Epilepsy, Bipolar Disorder
Subvenite (lamotrigine) is an oral suspension formulation of the approved anticonvulsant lamotrigine for use in the treatment of epilepsy and bipolar disorder.
- 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.
Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of Subvenite in the acute treatment of mood episodes has not been established.
Development timeline for Subvenite
Further information
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