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Valeant, Activis Call Truce Over Xifaxan

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Valeant and Activis have agreed to extend stay on Actavis' Abbreviated New Drug Application or ANDA for generic version of Xifaxan 550 mg tablets. The stay will be effective up to April 2018 and can not be lifted prior to October end.

Valeant's Xifaxan and Actavis' eluxadoline with the brand name Viberzi are both intended for irritable bowel syndrome and were approved by the Food and Drug Administration in May, 2015. The litigation was moved by Valeant against Actavis on its generic version in March last year. It had also filed a Citizen petition with the regulator in October.

The trial on the litigation was scheduled in January 2018.

FDA said it will no longer look for a bio-equivalence study with clinical endpoints in order to establish bio-equivalence.

Xifaxan has been one of the best selling drugs for Valeant with an annual sales of around $1 billion. It enjoys patent protection until 2029. Valeant has been trying to avoid generics to enter market, prior to that period.

Valeant had made Xifaxan its own through the acquisition of Salix Pharmaceuticals for around $11 billion in April 2015.

by RTT Staff Writer

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