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