FDA requests more data on AstraZeneca diabetes treatment

AstraZeneca said the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) about the new drug application (NDA) for the investigational fixed-dose combination of saxagliptin and dapagliflozin. The fixed-dose combination of saxagliptin and dapagliflozi is intended for the treatment of adult patients with Type 2 diabetes.  The CRL said more clinical data is required to support NDA. Read More »