FDA approves Crestor sNDA

FDA approved an sNDA from AstraZeneca plc (LSE:AZN; NYSE:AZN) for Crestor rosuvastatin to reduce the risk of stroke, myocardial infarction and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease. The company said FDA did not request additional follow-on trials or a safety registry to assess/monitor the risk of diabetes in patients taking the drug. In December, an FDA panel suggested that the agency request follow-on trials or a safety registry (See BioCentury Extra, Tuesday, Dec. 15, 2009). ...