Medication Guide App

Cialis erectile dysfunction treatment moves closer to approval

Cialis erectile dysfunction treatment moves closer to approval

INDIANAPOLIS INDIANA -- Lilly ICOS LLC announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Cialis (tadalafil).

Lilly ICOS is seeking approval of Cialis (pronounced: se-al-is), its investigational oral PDE5 inhibitor, for the treatment of erectile dysfunction. FDA approval is contingent upon successful completion of additional clinical pharmacology studies, labeling discussions and manufacturing inspections.

Currently, a U.S. launch for Cialis is projected to take place in 2003.

"Based on its clinical profile, we are confident in the value and potential of Cialis," said Paul Clark, ICOS chairman and chief executive officer. "This action by the FDA brings Cialis one step closer to approval in the U.S., and we are confident Lilly ICOS can fulfill the FDA's additional requests in a timely manner."

"We are committed to making Cialis an available treatment option for the more than 30 million American men who are affected by erectile dysfunction," said Sidney Taurel, chairman, president, and chief executive officer of Eli Lilly and Company. "Lilly ICOS will continue working with the FDA to bring this innovative compound to market as expeditiously as possible."

Posted: May 2002


View comments

Hide
(web3)