Slow-moving FDA misses deadline on Takeda drug

Takeda says it is facing an eight-month delay before it gets an FDA decision on its new diabetes drug. The drug company says that the agency has set a decision date of June 26, 2009 for alogliptin, a DPP-4 inhibitor. The initial deadline was October 27 and initially the FDA said that it was late due to "internal resource constraints." The FDA has missed at least 15 deadlines in 2008.

Takeda is particularly anxious to get an approval on the drug. Actos, the best-selling diabetes drug, is losing patent protection in 2011 and the drug company needs alogliptin to replace lost revenue. Takeda notes that the agency is not looking for any new data.

- read Takeda's release [1]

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FDA delays review of Takeda's alogliptin [2]
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FDA approvals up in '08, missed deadlines abound [4]
FDA official says approval deadlines will be broken [5]