FDA Decision on Gout Drug Delayed for Routine Inspection

Takeda Pharmaceutical’s NDA for its gout treatment febuxostat didn’t receive a complete review by the Prescription Drug User Fee Act deadline. The FDA hasn’t raised concerns about the NDA or the data it contains on the drug, a once-daily oral treatment for hyperuricemia caused by gout, the company says in a statement. The agency said it couldn’t complete routine inspections of the clinical trial sites and a contract research organization by the Jan. 18 deadline.
Washington Drug Letter