19 OCT 2010 - Actavis has received approval from the FDA to market Zolpidem Tartrate Extended-Release Tablets, USP 6,25mg CIV in the United States. Distribution of the product has commenced.As the first company to file an ANDA that contained a paragraph IV certification for Ambien® CR 6,25mg, Actavis has been awarded 180-day exclusivity to market this product.
Zolpidem Tartrate extended-release tablets 6,25mg, the generic equivalent of Ambien® CR 6,25mg by Sanofi-Aventis, had US sales of approximately USD129 million for the 12 months ending 30 June, 2010 (IMS Health data)... Actavis' Press Release -
