Tag Archives: Drug Update

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 – 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), […]