FDA delays Takeda diabetes drug review for another six months

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Takeda Global Research and Development Center, a wholly owned U.S. subsidiary of the Osaka, Japan-based Takeda Pharmaceutical, has received notification that the FDA will respond to the alogliptin new drug application (NDA) by June 26.

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 date of Oct. 27, due to internal resource constraints. The FDA did not raise any issues with the data in the alogliptin NDA at that time.

The company said that Alogliptin, which was developed by its wholly owned U.S. subsidiary, Takeda San Diego as a dipeptidyl peptidase IV inhibitor, is being reviewed as an adjunct to diet and exercise for the treatment of type 2 diabetes.