Tadalafil oral film - Aquestive Therapeutics

Drug Profile

Tadalafil oral film - Aquestive Therapeutics

Alternative Names: AQST-119; Tadalafil PharmFilm

Latest Information Update: 22 Jan 2018

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At a glance

  • Originator MonoSol Rx
  • Developer Aquestive Therapeutics
  • Class Antihypertensives; Benzodioxoles; Carbolines; Erectile dysfunction therapies; Indoles; Pyridones; Small molecules; Vasodilators
  • Mechanism of Action Type 5 cyclic nucleotide phosphodiesterase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No
  • Available For Licensing Yes - Erectile dysfunction

Highest Development Phases

  • Preregistration Erectile dysfunction

Most Recent Events

  • 07 Feb 2017 Planned Prescription Drug User Fee Act (PDUFA) date for Erectile dysfunction in USA (PO) is 2017-09-18
  • 07 Feb 2017 The US FDA accepts NDA for tadalafil oral soluble film for Erectile dysfunction for review
  • 28 Nov 2016 Preregistration for Erectile dysfunction in USA (PO)
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