EATG » FDA approved class labeling revisions

FDA approved class labeling revisions

On February 14, 2017 FDA approved class labeling revisions regarding the risk of hepatitis B virus reactivation in patients coinfected with hepatitis C virus (HCV) and hepatitis B virus (HBV). The class labeling applies to the following HCV direct acting antiviral (DAA) agents:

  • Daklinza (daclatasvir)
  • Epclusa (sofosbuvir/velpatasvir)
  • Harvoni (ledipasvir/sofosbuvir)
  • Olysio (simeprevir)
  • Sovaldi (sofosbuvir)
  • Technivie (ombitasvir/paritaprevir/ritonavir)
  • Viekira Pak (ombitasvir/paritaprevir/ritonavir tablets; dasabuvir tablets)
  • Viekira XR (dasabuvir/ombitasvir/paritaprevir/ritonavir)
  • Zepatier (elbasvir/grazoprevir).

The key messages from the class labeling revisions are summarized here.

Source:
FDA
News categories: Hepatitis, EMA/FDA