Letter to the FDA Opposing Approval of the Drug AMX0035 for Treatment of Amyotrophic Lateral Sclerosis

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In a letter to the Food and Drug Administration regarding whether the combination drug AMX0035 (sodium phenylbutyrate and taurursodiol) should be approved for treating amyotrophic lateral sclerosis, Public Citizen argued against approval because the data from a clinical trial of the drug failed to provide substantial evidence of effectiveness.

October 24, 2022, FDA response letter.