Zydus Lifesciences Rifaximin Tablets bags USFDA tentative nod for irritable bowel syndrome with diarrhoea

Ahmedabad: Pharma major, Zydus Lifesciences Limited, 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.

Irritable bowel syndrome (IBS) is an episodic gastrointestinal (GI) disorder that is affecting a significant proportion of population, with a calculated approximate prevalence of 11.2% (1) . IBS has a strong impact on health-related quality of life, with its consequences in reduced work productivity, increased absenteeism and elevated health care use and costs. The cardinal symptoms of IBS include bloating and abdominal pain/discomfort associated with changes in bowel habits.

As per WHO, Diarrhoea is defined as the passage of 3 or more loose or liquid stools per day (or more frequent passage than is normal for the individual). Frequent passing of formed stools is not diarrhoea, nor is the passing of loose, pasty stools by breastfed babies.

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). The group now has 427 approvals and has so far filed 492* ANDAs since the commencement of the filing process in FY 2003-04.

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Medical Dialogues team had earlier reported that Zydus Lifesciences has also received final approval from the USFDA to manufacture Eluxadoline Tablets, 75 mg and 100 mg (USRLD: Viberzi Tablets, 75 mg and 100 mg), a mu-opioid receptor agonist, indicated in adults with IBS-D.

Read also: USFDA nod to Zydus Eluxadoline tablets for irritable bowel syndrome with diarrhoea

Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs.