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Letter to the FDA Opposing Approval of the New Drug Application for Droxidopa

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In a letter to the Food and Drug Administration (FDA) Public Citizen urges the agency to not approve the new drug application for droxidopa for treatment of patients with neurogenic orthostatic hypotension. There is insufficient evidence that the drug is effective or that the benefits of its use outweigh the risks. Given the lack of evidence that droxidopa is effective, FDA approval of the drug would undermine the integrity and meaningfulness of its own standard for approving drugs and cause immeasurable harm to the agency’s reputation.

February 12, 2014, Response Letter from the FDA.