04:24 PM EDT, 07/15/2024 (MT Newswires) -- Eton Pharmaceuticals ( ETON ) said late Monday that the US Food and Drug Administration accepted its new drug application for ET-400, the company's proprietary patented formulation of hydrocortisone oral solution.
Eton said the FDA assigned a prescription drug user fee act target action date of Feb. 28, 2025, by which the FDA must respond.
"We look forward to working with the FDA and preparing for a potential launch in early 2025," Chief Executive Sean Brynjelsen said.
Shares of the company were up about 12% in after-market activity.
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