Once-Daily Viekira Pak Under FDA Review

The FDA is taking into consideration a once-daily formulation of AbbVie’s ombitasvir, paritaprevir, and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak).

The FDA’s acceptance of the new drug application for the genotype 1 chronic hepatitis C virus infection was based on data from 2 studies.

The original formulation was approved in 2014 with a recommended dosage of 2 ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and 1 dasabuvir 250 mg tablet twice daily.


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