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AstraZeneca and Bristol-Myers Squibb Receive Complete Response Letter From FDA for Dapagliflozin
AstraZeneca Press Release (01/19/12)
AstraZeneca and Bristol-Myers Squibb have announced that the FDA has issued a complete response letter regarding the New Drug Application for investigational compound dapagliflozin for the treatment of type 2 diabetes in adults. The complete response letter requests additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. This includes clinical trial data from ongoing studies and may require information from new clinical trials.
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