FDA Issues Response Letter on Dapagliflozin

FDA Issues Response Letter on Dapagliflozin

The FDA has issued a complete response letter regarding the New Drug Application for investigational compound dapagliflozin (SGLT2) 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.