Zydus Cadila receives tentative approval from US FDA for Eluxadoline tablets

Zydus Cadila’s US subsidiary Zydus Pharmaceuticals (USA) Inc has received tentative approval from the US Food and Drug Administration (FDA) to market Eluxadoline tablets in the strengths of 75 mg and 100 mg, the company notified via a statement.

The statement further said that Zydus’ Eluxadoline tablets are indicated in adults for the treatment of irritable bowel syndrome with diaorrhea, or IBS-D. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.