sanofi-aventis is the world's third largest pharmaceutical company, has announced that the US Food and Drug Administration (FDA) have granted paediatric exclusivity for Ambien (zolpidem tartrate) and Ambien CR (zolpidem tartrate extended-release).
The decision was based on paediatric data submitted to the FDA, including results of a study in the paediatric population conducted following a written request from the FDA in December 2005.
sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines.