Testimony Before the FDA’s Nonprescription Drugs Advisory Committee on Montelukast (Singulair Allergy)
View the Presentation as a PDF.
Public Citizen strongly oppose Food and Drug Administration (FDA) approval of over-the-counter (OTC) montelukast because, relative to existing FDA-approved OTC products for allergic rhinitis, the drug: (1) offers marginal clinical benefit relative to placebo and generally appears to have inferior effectiveness compared to existing FDA-approved OTC allergy products and (2) poses significantly greater risk, both to patients who meet the proposed indication and to those likely to use the drug for off-label indications.