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 [e-mail]

(END) Dow Jones Newswires

June 28, 2023 07:27 ET (11:27 GMT)

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