Sanofi-Aventis Receives Pediatric Exclusivity For Ambien® And Ambien® CR

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sanofi-aventisSanofi-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.

About sanofi-aventis

Sanofi-aventis is the world's third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

source - Pharma Lexicon