Tag Archives: FDA Approval

In March there were three new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were four supplemental drug approvals. The FDA had acted on the assignment of new PDUFA dates for ten new products for review. Finally, there was one product that had an extension of a PDUFA […]

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 […]

  The pace of advancement in genetics and precision medicine is staggering. Today, there are more than 75,000 genetic testing products on the market, and more than ⅓ of therapies in the development pipeline are for molecularly-defined conditions. In this webinar, experts in genetic testing, drug spend, and claims payment automation will provide practical insight […]

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 […]

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), […]