EATG » FDA revises Evotaz label

FDA revises Evotaz label

The Evotaz (atazanavir/cobicistat) label was updated to include the 144 week data from trial 114 that evaluated the safety and efficacy of atazanavir co-administered with cobicistat in HIV-1 infected treatment-naïve subjects with baseline estimated creatinine clearance above 70 mL/min. Additionally the label was updated to add drug interaction information for elbasvir and grazoprevir, and to revise subsections 8.1 and 8.2 according to the Pregnancy and Lactation Labeling Rule.

The major changes are summarized here.

News categories: EMA/FDA