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

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
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Published On 2025-03-17 07:15 GMT   |   Update On 2025-03-17 07:15 GMT
USFDA nod to Zydus Eluxadoline tablets for irritable bowel syndrome with diarrhoea
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Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Eluxadoline Tablets, 75 mg and 100 mg (USRLD: Viberzi Tablets, 75 mg and 100 mg).

Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-D). 

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.

Eluxadoline tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad.

"Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Eluxadoline Tablets, 75 mg and 100 mg. With this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for Eluxadoline Tablets, 75 mg and 100 mg," the Company stated in a BSE filing.

Eluxadoline tablets had annual sales of USD 243.7 mn in the United States (IQVIA MAT January 2025). The group now has 419 approvals and has so far filed 483* ANDAs since the commencement of the filing process in FY 2003-04.

Read also: Zydus Lifesciences venture capital arm injects in Illexcor Therapeutics to advance novel oral therapy for sickle cell disease

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: CDSCO Panel suggests revising phase III CT protocol of Zydus Healthcare's Empagliflozin plus Metoprolol Succinate FDC

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