Actavis receives final FDA approval for Zolpidem ER Tablets

Actavis, an international generic pharmaceuticals company, today announced that it has received final approval from the US Food & Drug Administration to market Zolpidem Tartrate Extended-Release Tablets USP, 12.5 mg CIV.  Distribution of the product has commenced.  

Actavis was the first company to launch Zolpidem Tartrate Extended-Release Tablets 6.25 mg strength in October 2010 with 180-day exclusivity.

Zolpidem Tartrate Extended-Release Tablets, the generic equivalent of Ambien® CR , had US sales of approximately $793 million for the 12 months ending March 31, 2011, according to IMS Health.    

Commenting on the new approval, Doug Boothe, CEO of Actavis in the US, said:

"The approval of Zolpidem ER Tablets 12.5 mg enables Actavis to offer both strengths to meet the needs of our customers.  This approval also underscores Actavis' emphasis and commitment to bringing complex controlled-release products to the marketplace to help improve patient access to pharmaceuticals."