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Cialis Alcohol Interaction Among Key Factors Preventing First-Cycle Approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Lilly/Icos’ handling of Cialis’ interaction with alcohol appears to have been a sore point with FDA, review documents for the erectile dysfunction therapy indicate.

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Cialis’ distinguishing feature – its longer window for efficacy than competing erectile dysfunction agents – also triggered concerns about a longer window for safety problems with the Lilly/Icos drug, FDA review documents indicate.

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Lilly/Icos’ Cialis NDA was based on Phase III studies conducted outside the U.S. after FDA advised the firm at an end-of-Phase II meeting to delay pivotal studies until potential testicular toxicity could be investigated, FDA review documents show.

Lilly/Icos Cialis Development Strategy: FDA Delays Phase IIIs – Go Overseas

Lilly/Icos’ Cialis NDA was based on Phase III studies conducted outside the U.S. after FDA advised the firm at an end-of-Phase II meeting to delay pivotal studies until potential testicular toxicity could be investigated, FDA review documents show.

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