SOURCE: Actavis

August 19, 2008 01:13 ET

Actavis receives approval of generic Wellbutrin XL® 300mg in the United States

HAFNARFJORDUR, ICELAND--(Marketwire - August 19, 2008) - Reykjavik, Iceland, 19 August 2008 - - Actavis Group, the international generic pharmaceuticals company, today announced that it 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."

About Actavis

Actavis is one of the world's leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. With headquarters in Iceland, Actavis has operations in 40 countries, with 11,000 employees. The United States is the company's single largest market. Actavis' US operations are located in New Jersey, Maryland, North Carolina and Florida.

More information about Actavis Group can be found at www.actavis.com

Inquiries
David Myers, Jr.
Manager, Products & Communications
Tel: (973)993-4503
E-mail: dmyers@actavis.com

Hjordis Arnadottir
Corporate Communications
Tel: (+354) 535 2300
E-mail: harnadottir@actavis.com

Any statements contained in this press release that refer to Actavis' estimated or anticipated future results or future activities are forward-looking statements which reflect the Company's current analysis of existing trends, information and plans. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially depending on factors such as the availability of resources, the timing and effect of regulatory actions, the success of new products, the strength of competition, the success of research and development issues, unexpected contract breaches or terminations, exposure to product liability and other lawsuits, the effect of currency fluctuations and other factors.

Copyright © Hugin AS 2008. All rights reserved.

Contact Information