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# Eton Pharma Gets Complete Response Letter
- URL: https://www.fdaweb.com/eton-pharma-gets-complete-response-letter/
- Published: 2023-06-28T12:00:00.000Z
- Updated: 2026-09-14T18:41:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154791

FDA has issued Eton Pharmaceuticals a second complete response letter (CRL) on its NDA for dehydrated alcohol injection for treating methanol poisoning, citing chemistry manufacturing and controls issues. The company says all issues in the CRL are “addressable” and it will develop a comprehensive action plan to address the concerns.

In 2021, Eton received a CRL on the NDA that said the application could not be approved in its present form, according to the company. It also cited a pre-approval inspection of the product’s European contract manufacturer was pending due to then-Covid-related travel restrictions.