Shares of pharmaceutical company Eton Pharmaceuticals (NASDAQ:ETON) are sliding lower today after it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) over its new drug application (NDA) for dehydrated alcohol injection targeted for the treatment of methanol poisoning.
While the regulatory body has pointed out issues associated with Chemistry Manufacturing and Controls in the NDA, Eton noted that the issues are addressable. The company is now working on an action plan to address the concerns raised.
Eton already has three products on the market alongside four pipeline assets under development. Sean Brynjelsen, the CEO of the company commented, “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.”
After rising nearly 39.8% so far this year, Eton shares are down nearly 19% at the time of writing today.
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