Lilly ICOS Cialis complete response
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Lilly ICOS submits a complete response to FDA's April 2002 "approvable" letter for Cialis (tadalafil), the firm announces July 1. The second quarter 2003 submission extends the action date to the fourth quarter of 2003 and contains "clinical pharmacology and other data" requested by FDA. The agency also requested pharmacology studies for Bayer's competing erectile dysfunction therapy, Levitra (vardenafil), which became approvable in July 2002 (1Pharmaceutical Approvals Monthly Aug. 1, 2002, In Brief)...
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Lilly ICOS submits a complete response to FDA's April 2002 "approvable" letter for Cialis (tadalafil), the firm announces July 1. The second quarter 2003 submission extends the action date to the fourth quarter of 2003 and contains "clinical pharmacology and other data" requested by FDA. The agency also requested pharmacology studies for Bayer's competing erectile dysfunction therapy, Levitra (vardenafil), which became approvable in July 2002 (1 Pharmaceutical Approvals Monthly Aug. 1, 2002, In Brief).... |