Aries gets FDA green light for Aemcolo
Aries Pharmaceuticals has received the Food and Drug Administration’s clearance for Aemcolo (rifamycin) 194 mg delayed-release tablets, a new minimally absorbed antibiotic that is delivered to the colon for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of E. coli.
In October 2017, the FDA granted Qualified Infectious Disease Product and Fast Track designations for Aemcolo.
The product will be available in pharmacies in the first quarter of 2019, the company said
“Travelers’ diarrhea can be highly disruptive and cause significant discomfort for patients, and, in some cases, it can progress to more serious conditions if not treated effectively. The recent approval of Aemcolo is an important step for Aries as we continue to grow our portfolio to address important unmet needs in the GI community,” Aries Pharmaceuticals CEO Tom Joyce said.
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