Eton Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for ET-600, a proprietary patented formulation of desmopressin oral solution. This development marks a significant step forward in the regulatory review process, with the FDA assigning a Prescription Drug User Fee Act (PDUFA) target action date of February 25, 2026. If approved, ET-600 will be the only oral liquid option available on the market to deliver precise doses for pediatric patients. The product has patent protection through 2044, and Eton is preparing for a potential launch in the first quarter of 2026.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Eton Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9490416-en) on July 08, 2025, and is solely responsible for the information contained therein.