Eton Pharma Gets FDA Acceptance of NDA Response for Dehydrated Alcohol Injection

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 [e-mail]

(END) Dow Jones Newswires

01-11-23 0714ET