Eton Pharmaceuticals Receives Complete Response Letter (CRL) for Dehydrated Alcohol Injection
28 June 2023 - 8:50PM
Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative
pharmaceutical company focused on developing and commercializing
treatments for rare diseases, announced today that the U.S. Food
and Drug Administration (FDA) issued a Complete Response Letter
(CRL) in response to its New Drug Application (NDA) for dehydrated
alcohol injection for the treatment of methanol poisoning. The
issues raised in the CRL relate primarily to Chemistry
Manufacturing and Controls (CMC). 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.
About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is an innovative pharmaceutical
company focused on developing and commercializing treatments for
rare diseases. The Company currently has three FDA-approved
products in ALKINDI SPRINKLE®, Carglumic Acid tablets, and Betaine
Anhydrous for oral solution, and four late-stage pipeline
candidates under development with dehydrated alcohol injection,
ZENEO® hydrocortisone autoinjector, ET-400, and ET-600. In
addition, the Company receives royalties and is entitled to receive
milestone payments on other products. For more information, please
visit our website at www.etonpharma.com.
Investor Relations:Lisa M. Wilson, In-Site
Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com
Source: Eton Pharmaceuticals.
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