OWP Pharmaceuticals Announces FDA Filing Acceptance For New Drug Application Of SUBVENITE (lamotrigine) Oral Suspension

OWP Pharmaceuticals, Inc. is a privately held, commercial-stage neuroscience specialty pharmaceutical company, dedicated to developing and commercializing novel oral liquid formulations.

OWP announced today that it has received U.S. Food and Drug Administration (FDA) acceptance for the New Drug Application (NDA) submission of SUBVENITE (lamotrigine) oral suspension, which is the first oral liquid of lamotrigine indicated to treat epilepsy and bipolar disorder. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of January 3rd, 2025.

Scott Boyer, founder and chief executive officer of OWP stated, “We are incredibly excited to have received FDA acceptance of our NDA, which brings us closer to bringing the first oral liquid of lamotrigine to the US market.”

This milestone marks OWP Pharmaceuticals’ first FDA acceptance of an NDA in a pipeline of six oral liquids being developed through a 505(b)(2) pathway, including lamotrigine, topiramate, quetiapine fumarate, trazodone hydrochloride, atomoxetine hydrochloride and duloxetine hydrochloride.