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Eton Pharmaceuticals Says Received CRL From FDA Related to NDA For ET-105, Citing 'Dosing and Administration related topics that Eton had outlined in its press release on February 19, 2020'

On March 17, 2020, as expected, Eton’s partner received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) related to the New Drug Application for ET-105. The FDA’s letter primarily

Benzinga · 03/18/2020 12:13

On March 17, 2020, as expected, Eton’s partner received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) related to the New Drug Application for ET-105. The FDA’s letter primarily cited the Dosing and Administration related topics that Eton had outlined in its press release on February 19, 2020. The letter also contained minor questions and clarifications related to the Product Quality section of the review. Eton continues to believe that all issues in the letter can be resolved and addressed in a resubmission during the second or third quarter of this year.