Posted by Michael Wonder on 18 Nov 2018
Aquestive Therapeutics receives complete response letter from U.S. FDA for tadalafil oral film
16 November 2018 - Aquestive Therapeutics today announced it received a complete response letter from the U.S. FDA in regards to its new drug application for tadalafil oral film.
Tadalafil is a PDE5 inhibitor currently marketed in tablet form for the treatment of erectile dysfunction and benign prostatic hyperplasia under the brand name Cialis, and for treatment of pulmonary arterial hypertension under the brand name Adcirca.
In the letter, the FDA requested limited additional data from healthy volunteers. The company has also notified the agency about its plans to engage an alternative supplier of the active pharmaceutical ingredient.
