Healthcare Industry News:  Wellbutrin 

Biopharmaceuticals Generics FDA

 News Release - March 28, 2008

Actavis Receives Approval of Generic Wellbutrin SR(R) and Zyban(R) Tablets in the U.S.

MORRISTOWN, N.J., March 28 (HSMN NewsFeed) -. Actavis Group, the international generic pharmaceuticals company, today announced that it has received two separate approvals from the U.S. Food & Drug Administration to market Bupropion Hydrochloride extended-release tablets (SR). Distribution of the products will commence immediately.

Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Wellbutrin SR® and are indicated for the treatment of major depressive disorder. Annual sales of brand and generic Wellbutrin SR® were US$ 498 million for the 12 months ending December 2007 according to IMS Health data.

Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Zyban® and are indicated as an aid to smoking cessation treatment. Annual sales of brand and generic Zyban® were US$ 12 million for the 12 months ending December 2007 according to IMS Health data.

Commenting on the new approvals, Terry Fullem, Vice President of Marketing and Portfolio in the U.S. said:

"These approvals further enhance our strength in the area of modified release products and provide valuable options to our customers and patients."

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' U.S. operations are located in New Jersey, Maryland, North Carolina and Florida.

More information about Actavis in the United States can be found at http://www.actavis.us.

Information in this press release may contain forward-looking statements with respect to the financial condition, results of operations and businesses of Actavis. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among other things, exchange rate fluctuations, the risk that research and development will not yield new products that achieve commercial success, the impact of competition, price controls and price reductions, the risk of loss or expiration of patents or trade marks, difficulties of obtaining and maintaining governmental approvals for products, the risk of substantial product liability claims, exposure to environmental liability.


Source: Actavis

Issuer of this News Release is solely responsible for its content.
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