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Eton Pharmaceuticals Inc (ETON) has received a Complete Response Letter (CRL) from the FDA related to a marketing application for its dehydrated alcohol injection to treat 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 of the product's European contract manufacturer is pending. The company believes all other FDA questions raised in the letter can be fully addressed in a response in the coming months.

Price Action: ETON shares are down 29.3% at $6 in the premarket session on the last check Friday.