Sunday, October 12, 2008

FDA Continues Review of Takeda's New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes

Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.

The details can be read here.

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