- 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.
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