Zydus Cadila receives tentative USFDA approval for Eluxadoline Tablets


Ahmedabad : Zydus Cadila’s U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the USFDA to market Eluxadoline Tablets in the strengths of 75 mg and 100 mg (US RLD: VIBERZI® Tablets). Zydus’ Eluxadoline Tablets are indicated in adults for the treatment of irritable bowel syndrome with diarrhea, or IBS-D. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 324 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

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