Tag Archives: Drug Approvals

2017 was a busy year for the Food and Drug Administration (FDA) with a 100 percent score in meeting the assigned (Prescription Drug User Fee Act) PDUFA dates for 46 products. Of these products 33% were first in class, 39% had an orphan designation, 85% were approved on the first review, and 78% were approved […]

RJHS – Drug Alert FDA Drug Approval – Ibalizumab-uiyk (TrogarzoTM) On March 6, 2018, the U.S. Food and Drug Administration (FDA) approved a first in class treatment for adults with multi-drug resistant (MDR) HIV-1 infection, with a manufacturer’s initial estimated annual treatment cost of $118,000. An initial overview is listed below.  For additional Information on […]