Eton Pharma Gets FDA Acceptance of NDA Response for Dehydrated Alcohol Injection
11 January 2023 - 11:29PM
Dow Jones News
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)
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