FDA declines to approve new oral film ED drug

Nov. 19, 2018

The FDA has declined to approve an oral film male enhancement drug developed by Aquestive Therapeutics. 

Aquestive said it received a complete response letter from the FDA, signaling that the application could not be approved in its current form. But the company also stated that the FDA’s concerns were “manageable,” and that it shouldn’t impact the planned timeline for the drug’s rollout.  

The company hopes that its oral film formulation of the drug, tadalafil, will become a rival to Pfizer’s blockbuster Viagra. Tadalafil is the active ingredient in Cialis and like Viagra, is a PDE5 inhibitor. 

Read the full Reuters report.