December 5, 2022

Zydus Cadila receives tentative approval from USFDA for Eluxadoline Tablets

NEW DELHI: 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.

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