Eton Pharmaceuticals Receives Complete Response Letter from U.S. FDA for Dehydrated Alcohol Injection
DEER PARK, Ill., May 28, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (Nasdaq: ETON), today announced that the company has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) in response to the submission of its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning. The CRL indicated that the FDA has completed its review of the application and has determined that the application cannot be approved in its present form. A Pre-Approval Inspection (PAI) of the product’s European contract manufacturer is pending due to what the company believes are COVID-related travel restrictions. The company believes all other FDA questions raised in the letter can be fully addressed in a response in the coming months.
About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from three FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, and Alaway Preservative Free®, and has six additional products that have been submitted to the FDA.
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