Sanofi’s effort to switch erectile dysfunction pill Cialis to over-the-counter (OTC) availability from its original prescription status has been slowed to a grinding halt with the FDA’s decision to put a trial on hold.
The FDA halted an “actual use trial” intended to study the potential switch over problems with protocol design, Sanofi said in a statement. The trial has not yet recruited patients. The FDA has a detailed process when deciding allowance of a drug’s switch from prescription to OTC.
