Zydus Life receives final approval from USFDA for Eluxadoline Tablets – CNBC TV18

Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) to manufacture Eluxadoline 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.

Eluxadoline tablets will be produced at Zydus Lifesciences

Ltd (SEZ) in Ahmedabad, the company said in an exchange filing.

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.

Eluxadoline tablets had annual sales of $243.7 million in the US.

The group now has 419 approvals and has so far filed 483 (as of Dec 31, 2024) ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Ltd. settled nearly 1% lower on Thursday at Rs 880.