The Food and Drug Administration (FDA) has accepted for review a New Drug Application for ET-105, a new liquid formulation of lamotrigine.

The ET-105 formula is being developed specifically for patients with dysphagia and pediatric patients requiring dosing at levels below the currently available tablet strengths. According to the Company, ET-105 dosing delivery system will allow for measurements down to 1mg.

“Our team looks forward to working with Aucta and the FDA over the coming months as we prepare for a potential commercial launch in the first half of 2020,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. 

The Company is seeking approval of ET-105 as an adjunct therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients 2 years of age and older.

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A Prescription Drug User Fee Act (PDUFA) date of March 17, 2020 has been set for this application.

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