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indacaterol (ARCAPTA NEOHALER)

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    These comments from the Public Citizen Health Research Group are being submitted in follow-up to our testimony presented at the March 8, 2011 meeting of the Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) regarding the drug indacaterol maleate (Arcapta™ Neohaler™).
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    We hereby request that the Office for Human Research Protections (OHRP) conduct a compliance oversight evaluation of several unethicals trials of indacaterol maleate (Arcapta Neohaler)
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    In the interests of protecting the public health, the FDA should not approve indacaterol at the proposed doses of 75 and 150 mcg.

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