Drug news
FDA issues Complete Response Letter for dapagliflozin (AstraZeneca/BMS) for Type 2 Diabetes
The FDA has issued a Complete Response Letter regarding the New Drug Application for investigational compound dapagliflozin from BMS/AstraZeneca for the treatment of Type 2 Diabetes in adults. Dapagliflozin is a once a day, SGLT 2 inhibitor. 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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