FDA delays decision on Takeda's febuxostat
The US Food and Drug Administration says it will not be able to complete its review of the New Drug Application for Japanese drug major Takeda's hyperuricemia treatment febuxostat by its action date deadline, because of delays in carrying out routine inspections at investigator sites.
The agency raised no issues with the NDA submission or the data included in it, said Dean Sundberg, senior vice president, regulatory affairs, at the Takeda Global Research & Development Center.
"Takeda has taken all necessary steps and provided all necessary information at this point in the NDA review process and we await FDA's completion of these routine inspections and look forward to receiving a final approval date for febuxostat," he added.
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