Tag Archives: Drug Approvals

In July there were six new drug approvals by the FDA we deemed specific to the specialty market, three of the approvals were for biosimilar products. In addition, there were 2 supplemental drug approvals. The FDA had acted on assignment of eight new product reviews. Drugs included in this review are generally regarded by the […]

In June there were four new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were 12 supplemental drug approvals. The FDA had acted on assignment of six new product reviews. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include anticipated […]

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 […]

RJH – 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 […]