FDA panels to discuss aztreonam, Crestor

FDA's Anti-Infective Drugs Advisory Committee will meet on Dec. 10 to discuss an NDA from Gilead Sciences Inc. (NASDAQ:GILD) for an inhaled formulation of aztreonam lysine to treat infections due to Pseudomonas aeruginosa in cystic fibrosis patients. The PDUFA date was not disclosed. In September 2008, Gilead received a complete response letter for aztreonam in which FDA requested an additional trial. Gilead was down $0.40 to $43.43 on Monday.

On Dec. 15, the Endocrinologic and Metabolic Drugs Advisory Committee will meet to discuss an sNDA from AstraZeneca plc (LSE:AZN; NYSE:AZN) for Crestor rosuvastatin for the primary prevention of cardiovascular disease based on results from the Phase III JUPITER trial. The company expects a decision on the application in 1Q10. Crestor, an HMG-CoA reductase inhibitor, is approved to treat primary hyperlipidemia, mixed dyslipidemia, hypertriglyceridemia and homozygous familial hypercholesterolemia, and to slow the progression of atherosclerosis. ...