OTC Approval for Cialis Being Sought

Indianapolis, IN— Eli Lilly & Co. has struck a licensing deal allowing Sanofi SA to sell a nonprescription version of its erectile dysfunction drug tadalafil (Cialis) in major markets if regulators approve. Sanofi has acquired the exclusive rights to seek regulatory approval for OTC Cialis in the United States, Europe, Canada, and Australia, and to begin selling it after certain patents expire in 2017. The companies say that OTC availability could provide easier treatment access for impotence sufferers and also help reduce the online sale of counterfeit or stolen erectile dysfunction drugs. But there are still obstacles to gaining OTC approval, especially safety concerns. Cialis, like other PDE5 inhibitors, can cause a sudden drop in blood pressure if taken with certain heart and blood pressure medications, causing fainting or even death.