Eton Pharmaceuticals announces PDUFA date for ET-400 NDA

Eton Pharmaceuticals announced the company’s new drug application, or NDA, for ET-400, a proprietary patented formulation of hydrocortisone oral solution, has been accepted by the FDA and has been assigned a Prescription Drug User Fee Act, or PDUFA, target action date of February 28, 2025. ET-400 is a proprietary room temperature stable formulation of oral hydrocortisone solution. The company has been issued a patent related to the product by the U.S. Patent and Trademark Office that expires in 2043 and has additional patent applications currently under review.