combination product: Vosevi. It is use for treatment of adults with chronic hepatitis C virus (HCV) genotypes 1–6 without cirrhosis or with mild cirrhosis. It’s department is under Biologics Regulation, CBER. And requires Premarket Approval Application (PMA). A CBER -> IND, (Phase 1,2,3) or Pivotal Trials, BLA

Reference:

http://www.pharmaceutical-journal.com/news-and-analysis/news-in-brief/combination-treatment-for-hepatitis-c-approved-by-fda/20203228.article