Cosmo Pharmaceuticals NV said the U.S. Food and Drug Administration has accepted for review the application for its drug Aemcolo to treat patients with travelers' diarrhea.
The FDA expects to take an action by Nov. 16 on approval for the drug, which was previously granted qualified infectious disease product and fast-track designations by the regulator.
Aemcolo's new drug application is supported by the results of a late-stage clinical trial where the drug demonstrated superiority to placebo and noninferiority to ciprofloxacin, an antibiotic used to treat a number of bacterial infections, as a treatment of travelers' diarrhea.
If approved, the treatment will have five years market exclusivity period.
