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ETON Eton Pharmaceuticals Inc

3.75
0.00 (0.00%)
04 May 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type
Eton Pharmaceuticals Inc NASDAQ:ETON NASDAQ Common Stock
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 3.75 3.74 4.48 3.80 3.605 3.75 61,060 05:00:10

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

11/01/2023 12:29pm

Dow Jones News


Eton Pharmaceuticals (NASDAQ:ETON)
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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.

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