19 January 2012 - Bristol-Myers Squibb Company (NYSE:BMY) and AstraZeneca (LON:AZN) said on Wednesday that the US Food and Drug Administration (FDA) requested additional clinical data regarding their New Drug Application (NDA) for the investigational Type 2 diabetes drug dapagliflozin.

FDA's Complete Response letter requests additional data in order to ensure better assessment of the benefit-risk profile of the compound. This includes clinical data from ongoing trials and may require the launch of new clinical trials.

Bristol-Myers Squibb and AstraZeneca will work closely with the FDA to decide on their next steps for the dapagliflozin application. The companies also continue to have talks with health authorities in Europe and other countries over their application procedures.