Trials & Filings

FDA Accepts AbbVie’s NDA for Once-Daily VIEKIRA PAK

Fixed-dose formulation would replace twice daily regimen

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By: Kristin Brooks

Managing Editor, Contract Pharma

AbbVie’s NDA has been accepted by the FDA for a once-daily, fixed-dose formulation of the components of VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets). VIEKIRA PAK is an all-oral, interferon-free treatment approved with or without ribavirin (RBV) in the U.S. for genotype 1 (GT1) chronic hepatitis C virus (HCV) infection. This drug would compete with other, more convenient dosing regimens for HCV, including Gilead’s once-daily, single-tablet regimen Harvoni. ...

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