Public Citizen continues to press Meridia withdrawal
Executive Summary
Public Citizen submits second petition calling for FDA to ban Abbott's diet drug Meridia (sibutramine). The first petition, submitted March 19, 2002, cited 19 deaths from cardiovascular disease from February 1998 to September 2001. The 1second petition, submitted Sept. 3, includes 30 additional reports of cardiovascular deaths in Meridia patients. Abbott met with FDA Chief Counsel Dan Troy June 11 to discuss Meridia labeling (2"The Pink Sheet" July 21, 2003, In Brief)...
You may also be interested in...
Sanofi Chews The Fat: Rimonabant Anti-Obesity NDA To Be Filed By 2005
Sanofi-Synthelabo expects to file an NDA for rimonabant in obesity by the first quarter of 2005, Exec VP-Scientific Affairs Gerard Le Fur told analysts during a business review in London Sept. 2
Meridia labeling
Abbott met with FDA Chief Counsel Daniel Troy July 11 to discuss labeling issues for Meridia (sibutramine). Public Citizen's petition requesting withdrawal of the obesity agent has been pending at FDA since March 2002 (1"The Pink Sheet" March 25, 2002, p. 21)...
Sanofi Prepares Pulmonologists As Dupixent Nears COPD Finishing Line
The French drugmaker has identified education as a key challenge ahead of its June action date for the huge-selling IL4/IL-13 inhibitor in the lung condition. An approval would make it the first biologic for the disease.