By Chris Wack

Eton Pharmaceuticals Inc. said Wednesday that the U.S. Food and Drug Administration has accepted for review the company's New Drug Application response for dehydrated alcohol injection for the proposed indication of treating methanol poisoning.

The FDA has assigned a Prescription Drug User Fee Act target action date of June 27, 2023.

Eton's application has previously been granted orphan drug designation for the indication of methanol poisoning and if approved, the company expects the FDA to grant the application seven years of orphan drug exclusivity.

Eton shares were up 19% at $3.88 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

January 11, 2023 07:14 ET (12:14 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
Eton Pharmaceuticals (NASDAQ:ETON)
Historical Stock Chart
From Mar 2024 to Apr 2024 Click Here for more Eton Pharmaceuticals Charts.
Eton Pharmaceuticals (NASDAQ:ETON)
Historical Stock Chart
From Apr 2023 to Apr 2024 Click Here for more Eton Pharmaceuticals Charts.