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FDA Offers Up Revised PDUFA Date In June For Takeda’s Alogliptin

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA may be heeding stakeholder calls to set new action dates once an original user fee deadline is missed.

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More data needed for Takeda’s alogliptin

FDA will apply its December 2008 guidelines on cardiovascular risk assessment for type 2 diabetes drugs in its review of Takeda's DPP-4 inhibitor alogliptin, despite the fact that the drug company submitted its NDA prior to the published guidance. The agency informed Takeda March 6 that the amount of existing alogliptin clinical data is not sufficient to meet certain statistical requirements in the new guidance. In October 2008, the agency notified the drug company that it could not meet the PDUFA date due to internal resource constraints, but did not raise any issues with the data (1"The Pink Sheet" DAILY, Dec. 29, 2008). Takeda's new user fee date is June 26

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