The FDA informed Takeda that it will miss the review deadline for alogliptin, a type 2 diabetes treatment. The NDA was supposed to be reivewed by October 7, 2008. The good news for Takeda, however, is that the delay is not due to problems with the drug's applications, but "internal resource constraints" at the agency. "[T]he FDA did not provide Takeda with any guidance on when a review might be completed nor did it raise any issues with the data in the alogliptin NDA," said Dean Sundberg, senior vice president, regulatory affairs at Takeda.
- here's Takeda's release [1]
Related Articles:
Affymax, Takeda suspend ESA development [2]
Takeda case could be sign of tougher FDA stance [3]
September FDA news in review [4]
FDA staffing push yields 1,300 hires [5]
How the FDA will spend your fees [6]
Links:
[1] http://www.fiercebiotech.com/press-releases/fda-continues-review-takedas-new-drug-application-alogliptin-syr-322-dpp-4-agent-ty-0
[2] http://www.fiercebiotech.com/story/affymax-takeda-suspend-esa-development/2008-08-29
[3] http://www.fiercebiotech.com/story/takeda-case-could-be-sign-tougher-fda-stance/2007-11-01
[4] http://www.fiercepharma.com/special-reports/september-fda-news-review
[5] http://www.fiercepharma.com/story/fda-staffing-push-yields-1-300-hires/2008-09-12
[6] http://www.fiercepharma.com/story/how-the-fda-will-spend-your-fees/2008-05-08