India, March 17 -- Zydus Lifesciences Limited, along with its subsidiaries and affiliates, has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Eluxadoline Tablets (75 mg and 100 mg), the generic equivalent of Viberzi® Tablets.
Eluxadoline, a mu-opioid receptor agonist, is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. The tablets will be manufactured at Zydus Lifesciences Ltd (SEZ), Ahmedabad.
Zydus was among the first Abbreviated New Drug Application (ANDA) applicants to file a substantially complete ANDA with a Paragraph IV certification for these strengths. With this approval, Zydus gains 180 days of shared generic drug exclusivity for El...