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FDA Advertising Letters, In Brief

Executive Summary

Cialis web promotions: A Jan. 3 letter from FDA Division of Drug Marketing, Advertising & Communications objects to websites promoting the safety and efficacy of Lilly/Icos' unapproved erectile dysfunction product Cialis (tadalafil), including statements that Cialis enables "a man with ED to engage in intercourse within a 24-hour window" and "regain spontaneity;" that data suggests "dosing for Cialis should be simple and uncomplicated" and that "Cialis was well-tolerated, with generally mild-to-moderate side effects that diminished in frequency with continued treatment." Lilly said the companies will remove the identified items...

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