Lilly ICOS Cialis EU approval
This article was originally published in Pharmaceutical Approvals Monthly
Lilly ICOS' erectile dysfunction therapy Cialis (tadalafil) receives EU marketing approval Nov. 12 based on data package including 1,112 men in Phase III studies. Lilly projects U.S. approval in second half of 2003; FDA requested additional clinical pharmacological studies in an April 29 "approvable" letter. The firm says the Carolina, Puerto Rico facility where the U.S. product will be manufactured recently received a successful FDA inspectio
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