A professional detail aid for Flonase (fluticasone propionate) was found to be misleading because it made unsubstantiated superiority claims and omitted material facts.
According to the letter, the detail aid made the following claim of superiority over Nasonex (mometasone furoate): “Choose greater efficacy for your patients with seasonal allergic rhinitis …” and “Patients given Flonase experienced greater relieve of nasal symptoms in a head-to-head clinical study of seasonal allergenic rhinitis …”
FDA stated that these claims are misleading because they claim superiority over Nasonex and this has not been demonstrated by substantial evidence or clinical experience.
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The letter also noted that the detail aid highlighted congestion as a specific symptom for which the drug should be prescribed. However, Flonase is not indicated to treat nasal congestion. F-B; Lab; Doc. aldara. 14177W
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