Posted by Michael Wonder on 17 Feb 2018
Apricus Biosciences receives complete response letter from FDA for Vitaros
16 February 2018 - Company evaluating deficiencies and potential path forward.
Apricus Biosciences today announced that the U.S. FDA has issued a complete response letter for the new drug application of Vitaros (alprostadil), a topical cream for the treatment of erectile dysfunction.
The letter indicates that the FDA cannot approve the application for Vitaros in its present form, identifying deficiencies related to Chemistry, Manufacturing and Control and certain safety concerns specific to the 2.5% concentration of alprostadil contained in the current formulation.
