FDA Accepts NDA for Aemcolo (Rifamycin SV MMX) for Travelers' Diarrhea

Cosmo Pharmaceuticals N.V. (SIX: COPN) announced on 5/21/18 that the U.S. Food and Drug Administration (FDA) has set a PDUFA date of November 16, 2018 for its decision on the New Drug Application (NDA) for Aemcolo (Rifamycin SV MMX®) for the treatment of patients with travelers' diarrhea (TD). In October 2017, the FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for Aemcolo. Aries Pharmaceuticals, Inc., Cosmo's U.S. subsidiary based in San Diego, California, a specialty pharmaceutical company commercializing best-in-class gastroenterology products, will lead the commercial sales and marketing for Aemcolo, developed by Cosmo Pharmaceuticals, N.V., in the U.S.