FDA
- Status: approved
PB 6 doses - Rifampicin, Clofazimine and Dapsone (PB 6 doses - Rifampicin, Clofazimine and Dapsone) 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.
University of Brasilia is the originator. The local marketing authorisation holder may differ — check the official source linked above.