FDA accepts new drug application submission for Cosmo Pharmaceutical’s Rifamycin SV MMX and sets PDUFA date for November 16, 2018
Cosmo Pharmaceuticals N.V. today announced that it has been notified by the U.S. Food and Drug Administration that the Agency has accepted the filing of its New Drug Application (NDA) seeking market approval for Rifamycin SV MMX in the United States.