法国巴黎2006年11月29日
Sanofi-aventis公司宣布美国食品和药物管理局（FDA）批准Ambien® (zolpidem tartrate) and Ambien® CR (zolpidem tartrate extended-release) 思诺思在美国获得新适用人群－儿童.
FDA已批准赛诺菲-安万特公司的安眠药Ambien(zolpidem)用于儿童。
获准用于儿童的包括Ambien和AmbienCR(该药的控释型产品)，赛诺菲-安万特公司称这次批准的依据是FDA于12月份要求提交的相关数据。
SANOFI-AVENTIS RECEIVES PEDIATRIC EXCLUSIVITY
FOR AMBIEN® AND AMBIEN® CR
Paris, France, November 29, 2006 - Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for Ambien® (zolpidem tartrate) and Ambien® CR (zolpidem tartrate extended-release).
The decision was based on pediatric data submitted to the FDA, including results of a study in the pediatric population conducted following a written request from the FDA in December 2005
