Eton Pharma Gets FDA Complete Response Letter for Dehydrated Alcohol Injection
By Robb M. Stewart
Eton Pharmaceuticals said Wednesday the U.S. Food and Drug Administration issued a complete response letter in response to its new drug application for dehydrated alcohol injection for the treatment of methanol poisoning that raised certain issued.
In premarket trading, the pharmaceutical company's shares dropped 26% after ending Tuesday at $4.04, up 43% so far this year.
Eton said the issues raised in the complete response letter relate primarily to chemistry manufacturing and controls, and that it believes all issues in the letter are addressable. The company said it will develop a comprehensive action plan to address the FDA's concerns.
"While we are disappointed with the FDA's decision, our commercial business remains strong, and we are pleased that our momentum in product revenue growth has continued," Chief Executive Sean Brynjelsen said. "We expect to once again report record product revenue in the second quarter of 2023."
Write to Robb M. Stewart at robb.stewart@wsj.com
(END) Dow Jones Newswires
June 28, 2023 07:27 ET (11:27 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
Markets Brief: Tech Stocks Lead Ahead of Nvidia Earnings
-
How Anti-Obesity Drugs Are Innovating the Healthcare Market
-
What’s Happening In the Markets This Week
-
Why Immigration Has Boosted Job Gains and the Economy
-
What to Invest in During High Inflation
-
Never Mind Market Efficiency: Are the Markets Sensible?
-
Starbucks Stock Could Use a Pick-Me-Up After Big Selloff; Is it a Buy?
-
5 Cheap Stocks to Buy From an Attractive Part of the Market
-
The Best Bank Stocks to Buy
-
After Earnings, Is Roblox Stock a Buy, Sell, or Fairly Valued?
-
Should You Buy and Hold an Artificial Intelligence Portfolio?
-
After Earnings, Is Lyft Stock a Buy, a Sell, or Fairly Valued?
-
8 Stock Picks in the Apparel Industry
-
Baidu Earnings: Advertising Weakness Offset by Continued Growth In Cloud Business
-
Going Into Earnings, Is Target Stock a Buy, a Sell, or Fairly Valued?
-
Walmart Earnings: Low Prices and Strong Digital Presence Drive Market Share Gains