Eton Pharmaceuticals and Azurity Pharmaceuticals, Inc. announce FDA approval of Eprontia oral solution.
Eprontia has been approved as a monotherapy for treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; an adjunctive therapy for treatment of partial-onset seizures, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older; and as a preventive treatment of migraine in patients 12 years of age and older.
Eprontia is the first oral liquid formulation of topiramate to be approved by the FDA. Azurity will be responsible for commercializing the product and anticipates product availability before year end. Eton will receive a $5 million milestone payment upon Eprontia's commercial launch, a royalty on net sales, and potential commercial milestones.
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