Actavis has received final approval from the FDA 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.”
