The company has already started distribution of the Zolpidem Tartrate Extended-Release Tablets, the generic equivalent of Ambien CR.
Sanofi-aventis’ Ambien CR is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Actavis CEO Doug Boothe 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," Boothe said.