Takeda Pharmaceutical Co. Ltd. received notification that the FDA will not be able to complete its review of the alogliptin NDA by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.
The agency indicated that due to internal resource constraints it would not be able to complete the alogliptin review by the PDUFA date. According to a Takeda statement, the FDA did not provide guidance as to when the review might be completed. If the FDA does not complete its review of the NDA by the end of the year, development partner PDD will not receive the $25 million alogliptin approval milestone in 4Q08. The NDA was submitted in December 2007 for the treatment of type 2 diabetes.