US alogliptin review to miss action date
This article was originally published in Scrip
The US FDAwill not be able to complete its review of the NDA for Takeda's DPP-4 inhibitor alogliptin by the original Prescription Drug User Fee Act date of October 27th. The company said that the agency had pointed in recent discussions to internal resource constraints, and that it had not received any guidance on when the review for the type 2 diabetes therapy might be completed. No issues were raised with the data in the submission, and the company said it remained confident in the product's potential. The filing was made late last year and included data from six Phase III trials in a variety of regimens including as mono and combination therapy.
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