Zydus Cadila receives tentative approval for IBS tablets
Drug Approval

Zydus Cadila receives tentative approval for IBS tablets

The group now has 324 approvals and has so far filed over 400 ANDAs

  • By IPP Bureau | November 15, 2021

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 diarrhoea, 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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