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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 2025-06-02T12:58:31+05:30  |  Updated On 2 Jun 2025 12:58 PM IST
Zydus Lifesciences Rifaximin Tablets bags USFDA tentative approval for irritable bowel syndrome with diarrhoea
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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.

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.

Read also: Zydus Lifesciences bags USFDA nod for Glatiramer Acetate Injection for relapsing forms of Multiple Sclerosis

zydus lifescienceszydus lifesciences newsUSFDArifaximin tabletxifaxan tabletirritable bowel syndromediarrhoea
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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