EATG » FDA approves hepatitis C drugs label updates

FDA approves hepatitis C drugs label updates

FDA recently approved changes to the labels of:

  • Sovaldi (sofosbuvir), Harvoni (ledipasvir and sofosbuvir), Epclusa (sofosbuvir and velpatasvir) and Vosevi (sofosbuvir, velpatasvir, and voxilaprevir). The approved changes are detailed here.
  • VIEKIRA PAK™ (ombitasvir, paritaprevir, and ritonavir tablets, 12.5 mg/75 mg/50 mg; dasabuvir tablets, 250 mg), VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) and TECHNIVIE (ombitasvir, paritaprevir, and ritonavir). The approved changes are detailed here.
  • OLYSIO (simeprevir), DAKLINZA (daclatasvir) and ZEPATIER (grazoprevir/elbasvir). The approved changes are detailed here.
News categories: Hepatitis, EMA/FDA