Tag Archives: Drug Approvals

In February there were two new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were two supplemental drug approvals. The FDA had acted on assignment of new PDUFA dates for three new products for review. Finally, there was one complete response letter issued. Drugs included in this review […]

In January there was one new drug approval by the FDA we deemed specific to the specialty market. In addition, there were three supplemental drug approvals. The FDA had acted on assignment of new PDUFA dates for three new products for review. Finally, there were two complete response letters issued and one manufacturer triggered withdrawal […]

Enacted in 1992, the Prescription Drug User Fee Act (PDUFA) was created to authorize the Food and Drug Administration (FDA) to collect fees from companies that produce certain human drug and biological products. These fees serve as a secondary source of funding for the FDA and serve to expedite the review process.  The FDA establishes […]

In December there were a total of four new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were six supplemental drug approvals. The FDA had assigned eight new products for review. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include […]

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 […]