FDA
- Status: approved
Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir (Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir) regulatory status in United States.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA has authorised it.
Sherief Abd-Elsalam is the originator. The local marketing authorisation holder may differ — check the official source linked above.