Tag Archives: Drug Update

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 – lutetium Lu 177 dotatate ( LUTATHERA ®) Generic Name Brand Name Manufacturer Approval Date Anticipated Availability Accelerated Review lutetium Lu 177 dotatate Lutathera Advanced Accelerator Applications USA. Inc. 1/26/2018 Not available Priority Review with Orphan Drug Designation Labeled Indication: Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), […]