Delay For Sanofi’s OTC Cialis Study In US Could Be Sign of Hurdles Holding Back Other Switches

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.”

The latest example of the high bar for approval in the US to make available OTC drug ingredients indicated for chronic conditions is Sanofi’s initiative to make erection dysfunction drug Cialis available nonprescription the latest example.

Potential hurdles the Food and Drug Administration put in front of Sanofi’s planned switch of tadalafil to be the first...