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# Cosmo Pharma NDA for Travelers’ Diarrhea Antibiotic
- URL: https://www.fdaweb.com/cosmo-pharma-nda-for-travelers-diarrhea-antibiotic/
- Published: 2018-05-21T12:00:00.000Z
- Updated: 2026-09-15T00:06:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141490

FDA has accepted for review a Cosmo Pharmaceuticals NDA for Aemcolo (rifamycin SV MMX) for treating patients with travelers’ diarrhea. The agency has set a user fee review action target date of 11/16.

“Resistance to currently available antibiotics is a serious issue and there have been no new chemical entities approved to treat colonic infections in more than 10 years,” the company says. The therapy was granted both a Qualified Infectious Disease Product and Fast Track designation.

Aemcolo is a broad spectrum, semi-synthetic, orally administered, minimally absorbed antibiotic. In clinical trials, Aemcolo demonstrated superiority as compared to placebo and its non-inferiority as compared to ciprofloxacin, the company says.