Takeda's alogliptin NDA subject to new guidance

Japanese Takeda Pharmaceutical's US subsidiary has been informed that, although the company's New Drug Application for alogliptin was filed  prior to issuance of Food and Drug Administration's December 2008  guidance on new type 2 diabetes treatments, the agency will apply these  guidelines to its review.

Additionally, the FDA says that the amount of existing alogliptin  clinical data is sufficient to meet certain statistical requirements in  the new guidance. The agent's Prescription Drug User Fee Act date - June  26 - will remain unchanged, says the firm.

In October 2008, Takeda received notification from the FDA that it was  unable to complete its review of the alogliptin NDA by the original  PDUFA date - October 27 - due to internal resource constraints.