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Approvals In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer Revatio label warns of "visual disturbances": Mid-July launch of Revatio (sildenafil) is expected by Pfizer following NDA approval June 3 for "pulmonary arterial hypertension (World Health Organization Group 1) to improve exercise ability." A 277-patient, Phase III study showed statistically significant increases in six-minute walk distances compared with placebo. PAH afflicts about 100,000 worldwide. Common side effects include headache, dyspepsia, flushing, epistaxis and insomnia. Labeling includes a warning of the possibility of "visual disturbances" at doses higher than the recommended 20 mg three times daily. While Viagra for ED has the same active ingredient, Revatio has a lower dose size and higher frequency, and a different pill shape and color. The firm is in talks with FDA to revise Viagra labeling to reflect "rare" occurrences of non-arteritic anterior ischemic optic neuropathy, and expects to update labeling on potential vision loss...
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