| Takeda Receives New Action Date for Alogliptin (SYR-322) NDA |
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24/12/2008 02:29 (412 Day 20:19 minutes ago) | |||||
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The FINANCIAL -- Takeda Pharmaceutical Company Limited (“Takeda”) on December 24 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 respond to the alogliptin New Drug Application (NDA) by June 26, 2009.
In October 2008, Takeda received notification from the FDA that it was unable to complete its review of the alogliptin NDA by the original Prescription Drug User Fee Act (PDUFA) date — October 27, 2008 — due to internal resource constraints. The FDA did not raise any issues with the data in the alogliptin NDA at that time.
Alogliptin which was discovered by Takeda’s wholly owned U.S. subsidiary, Takeda San Diego, Inc. is a dipeptidyl peptidase IV (DPP-4) inhibitor being reviewed as an adjunct to diet and exercise for the treatment of type 2 diabetes. Alogliptin. In December 2007, Takeda submitted its NDA for alogliptin to the FDA.
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