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FDA fails to meet Takeda drug application deadline
19 Jan 2009
QA, QC & Validation
The US Food and Drug Administration (FDA) has failed to meet the deadline for its review of Takeda's new drug febuxostat, the firm has announced.
An assessment of the new drug application for the medication - used to treat hyperuricemia in patients with gout - was due to be completed by January 18th.
Dean Sundberg, senior vice president of regulatory affairs at Takeda Global Research and Development Centre, said the FDA did not raise any issues with the application or the attached data.
The FDA stated that it will miss the prescription drug user fee act date "due to its inability to complete routine inspections at investigator sites and at a clinical research organisation vendor involved in the development of febuxostat", Mr Sundberg affirmed.
Japanese firm Takeda recently appointed Stephan Ziegler as chief executive of its wholly-owned subsidiary Takeda Pharmaceuticals Asia Private Limited, which oversees sales and commercialisation in the Asian market.
