Eton Pharmaceuticals receives CRL from FDA for dehydrated alcohol injection

Eton Pharmaceuticals announced that the U.S. FDA issued a Complete Response Letter in response to its New Drug Application for dehydrated alcohol injection for the treatment of methanol poisoning. The issues raised in the CRL relate primarily to Chemistry Manufacturing and Controls. The company believes all issues in the CRL are addressable and 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. We expect to once again report record product revenue in the second quarter of 2023. With the recent addition of Betaine Anhydrous for Oral Solution to our commercial product portfolio, we are well positioned for continued sustainable long-term growth,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.