Bristol-Myers discloses FDA to review dapagliflozin again

Bristol-Myers Squibb Co. (NYSE:BMY) disclosed on its 2Q13 earnings call on Thursday that FDA accepted for review an NDA for Forxiga dapagliflozin to treat Type II diabetes. The PDUFA date is Jan. 11, 2014. BMS and co-development partner AstraZeneca plc (LSE:AZN; NYSE:AZN) received a complete response letter from FDA in January 2012, in which the agency asked for additional data to better assess the risk-benefit profile of the sodium-glucose cotransporter 2 (SGLT2) inhibitor. The European Commission approved Forxiga in November. ...