Eton Pharmaceuticals (ETON) PT Lowered to $11 at B.Riley on CRL

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Go back to Eton Pharmaceuticals (ETON) PT Lowered to $11 at B.Riley on CRL

Eton Pharmaceuticals Receives Complete Response Letter from U.S. FDA for Dehydrated Alcohol Injection

May 28, 2021 8:05 AM EDT

DEER PARK, Ill., May 28, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (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 products European contract manufacturer is pending... More