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

Zydus Lifesciences has acquired final approval from the US Meals and Drug Administration (USFDA) to fabricate Eluxadoline Tablets, 75 mg and 100 mg.

Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the therapy of irritable bowel syndrome with diarrhoea.

Eluxadoline tablets might be produced at Zydus Lifesciences

Ltd (SEZ) in Ahmedabad, the corporate stated in an change submitting.

Zydus was one of many first ANDA candidates to submit a considerably full 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 gross sales of $243.7 million within the US.

The group now has 419 approvals and has to date filed 483 (as of Dec 31, 2024) ANDAs because the graduation of the submitting course of in FY 2003-04.

Shares of Zydus Lifesciences Ltd. settled almost 1% decrease on Thursday at Rs 880.