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

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-06-02 07:28 GMT   |   Update On 2025-06-02 07:28 GMT

Ahmedabad: Pharma major, Zydus Lifesciences Limitedhas 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.

Read also: Zydus Lifesciences gets CDSCO Panel nod to study Aprepitant powder for Oral Suspension

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.

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News