FDA reviewing once-daily Viekira Pak

AbbVie Inc. (NYSE:ABBV) said FDA accepted an NDA for a once-daily fixed-dose formulation of Viekira Pak to treat chronic HCV genotype 1. AbbVie said it expects a decision on the candidate in 2H16, but did not respond to an inquiry about its PDUFA date.

AbbVie said the new formulation contains three tablets taken once daily with a meal, with or without twice-daily ribavirin. A twice-daily formulation of Viekira is approved in the U.S. with or without ribavirin to treat HCV genotype 1. ...