Seizure Disorders

FDA Approves Lamotrigine Oral Suspension Subvenite

Diana Ernst, RPh
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Publish Date
A calibrated measuring device, such as an oral dosing syringe or oral dosing cup, should be used to measure and deliver the prescribed dose accurately.

The Food and Drug Administration (FDA) has approved Subvenite®, an oral suspension formulation of lamotrigine.

Subvenite oral suspension contains 10mg per mL of lamotrigine, an antiepileptic drug (AED) of the phenyltriazine class. It is approved for the following indications:

  • Adjunctive therapy in patients aged 2 years and older with partial-onset seizures, primary generalized tonic-clonic seizures, or generalized seizures of Lennox-Gastaut syndrome.
  • For conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED.
  • For the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy.

Subvenite oral suspension is cherry-flavored and supplied in an 8oz bottle. The product can be stored at room temperature; any unused portion should be discarded 90 days after opening.

“The FDA approval of Subvenite Oral Suspension, the first and only lamotrigine oral suspension, represents a significant advancement in patient care,” said Scott Boyer, Founder and President, OWP Pharmaceuticals. “We are proud to bring this much needed treatment option to patients and clinicians, with availability anticipated in 2025.”

As with other lamotrigine products, there is a risk for serious skin rashes that may be life-threatening. Factors that may increase this risk include coadministration with valproate, exceeding the recommended initial dose of lamotrigine, or exceeding the recommended dose escalation for lamotrigine. Subvenite should generally be discontinued at the first sign of rash, unless the rash is clearly not drug related. 

A calibrated measuring device, such as an oral dosing syringe or oral dosing cup, should be used to measure and deliver the prescribed dose accurately.

This article originally appeared on MPR

References:
  1. OWP Pharmaceuticals announces FDA approval of Subvenite (lamotrigine) oral suspension. News release. OWP Pharmaceuticals. September 17, 2025. https://owppharma.com/owp-pharmaceuticals-announces-fda-approval-of-subvenite-lamotrigine-oral-suspension/.
  2. Subvenite. Package insert. OWP Pharmaceuticals; 2025. Accessed September 25, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218879s000lbl.pdf.