Delay For Sanofi’s OTC Cialis Study In US Could Be Sign of Hurdles Holding Back Other Switches
Executive Summary
Potential hurdles FDA put in front of Sanofi’s planned tadalafil switch could be sign for agency’s expectations for moving other Rx ingredients to OTC. Sanofi announced its planned actual use trial to support OTC tadalafil use was “placed on clinical hold due to matters surrounding the protocol design.”