> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Eton Pharmaceuticals ‘Complete Response’ on NDA
- URL: https://www.fdaweb.com/eton-pharmaceuticals-complete-response-on-nda/
- Published: 2021-05-28T12:00:00.000Z
- Updated: 2026-09-14T17:01:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149428

FDA has issued Eton Pharmaceuticals a complete response letter on its NDA for dehydrated alcohol injection for treating methanol poisoning. The company did not disclose specific concerns raised in the letter, but said all agency “questions” can be fully addressed in a response in the coming months. Eton also said a pre-approval inspection at the product’s European contract manufacturer is pending due to Covid-related travel restrictions.