Takeda receives FDA notification about new drug application

Takeda has been informed by the US Food and Drug Administration (FDA) that the body will not be able to finish its review of the alogliptin new drug application (NDA) by the Prescription Drug User Fee Act date of October 27th 2008.

In a statement, Takeda said the body explained that due to internal resource constraints, it would be unable to complete the review by the date.

“Although Takeda said the FDA did not provide any guidance on when a review might be completed, Takeda indicated that it remains confident in alogliptin’s potential as a new treatment option for people suffering from type 2 diabetes,” the site notes.

The firm stated it would continue to work with the FDA as the agency continues its NDA review.

Alogliptin is a dipeptidyl peptidase inhibitor which was discovered by the company’s wholly owned US subsidiary Takeda San Diego.

The firm submitted its NDA for alogliptin for the treatment of type 2 diabetes in December 2007.

In recent days, Takeda announced the London Symphony Orchestra is due to perform in Japan from November 27th to December 10th under the Takeda Global Concert Series programme, which it sponsors.