Lilly Icos completes US regulatory submission for Cialis

Lilly Icos LLC, a joint venture between Eli Lilly [LLY] and the Icos Corporation [ICOS], have submitted the additional data requested by the FDA on their Cialis anti-impotence drug.

In a media release Lilly Icos said the FDA had now accepted its submission as complete, after the regulator had earlier this year requested extra clinical pharmacology and other data.

Lilly Icos expects a final regulatory decision on Cialis late in the second half of 2003, following the FDA's review of the complete response, approval of Lilly's manufacturing facilities and completion of labeling discussions.