FDA Approves AEMCOLO™ (Rifamycin), the First Antibiotic Approved for the Treatment of Travelers’ Diarrhea in Over a Decade
Cosmo Pharmaceuticals N.V. announced that the U.S. Food and Drug Administration (FDA) has approved AEMCOLO™ (Rifamycin), containing 194mg of Rifamycin as delayed-release tablets, a new minimally-absorbed antibiotic that is delivered to the colon, for treatment of Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO, AEMCOLO should be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. In October 2017, the FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for
AEMCOLO. With the QIDP designation, intended for antibacterial or antifungal drugs
that treat serious or life-threatening infections, together with new chemical entity (NCE)
designation, marketing exclusivity for AEMCOLO runs through 2028. AEMCOLO will
be available in pharmacies in the first quarter of 2019.