Actavis has received approval from the US Food & Drug Administration to market Bupropion Hydrochloride extended-release tablets (XL) 300mg. Distribution of the product will commence immediately.
Bupropion Hydrochloride extended-release tablets (XL), available in 300mg strength, are the generic equivalent of Wellbutrin XL for the treatment of major depressive disorder. Annual US sales of brand and generic Wellbutrin XL 300mg were US$581 million for the 12 months ending June 2008 according to IMS Health data.
Commenting on the new approval, Douglas Boothe, chief executive officer of Actavis, Inc. in the United States, said: "Bupropion XL compliments our existing Bupropion SR offerings and expands the dosage options for our customers and patients. This approval also highlights Actavis Group's focus and expertise in bringing complex controlled-release technologies to the marketplace."