Powered by lexis nexis

FDA accepts New Drug Application for Methylene Blue MMX(TM) and sets PDUFA Date for May 21, 2018

Oct 16, 2017 - Business Wire

Aries Pharmaceuticals, Inc. (Aries), a specialty pharmaceutical company commercializing best-in-class gastroenterology products, today announced that the U.S. Food and Drug Administration (FDA) has set a PDUFA date of May 21st, 2018, for its decision on the New Drug Application (NDA) for Methylene Blue MMX(TM) (MB MMX). A Phase III clinical trial studied Methylene Blue MMX(TM) for the detection and visualization of pre-cancerous and cancerous lesions in people undergoing screening and surveillan...