FDA Continues NDA Review for Alogliptin

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 N...

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