Zydus Lifesciences receives USFDA tentative approval for Rifaximin Tablets

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Rifaximin Tablets, 550 mg (USRLD: Xifaxan' Tablets, 550 mg).

Rifaximin tablets are indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. Rifaximin tablets will be produced at the Group's manufacturing site at SEZ II, Ahmedabad.

Rifaximin tablets had annual sales of USD $2672.9 mn in the United States (IQVIA MAT March 2025).