Benzinga | May 28, 2021 08:37AM EDT

Eton Pharmaceuticals Stock Tumbles After FDA Rejects its Dehydrated Alcohol Injection Application For Methanol Poisoning

* Eton Pharmaceuticals Inc (NASDAQ: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.