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Actavis Receives Approval for Irinotecan Hydrochloride Injection; Extends US Portfolio with First Injectable Product

MORRISTOWN, N.J., Feb. 28 /PRNewswire/ -. Actavis Group, the international generic pharmaceuticals company, has received approval for Irinotecan Hydrochloride Injection from the U.S. Food & Drug Administration. Distribution of the product will begin immediately.

Irinotecan Hydrochloride Injection, the generic equivalent to Pfizer's Camptosar(R) will be available in 40 mg/2 mL and 100 mg/ 5 mL sizes and is used in the treatment of patients with metastatic carcinoma of the colon or rectum. Annual sales of Irinotecan Hydrochloride Injection in the United States were approximately US$556 million for the twelve months ending December 2007 according to IMS Health data.

Doug Boothe, Executive Vice President of US Commercial & Administration, said: "The launch of Irinotecan marks the expansion of Actavis' US portfolio into the injectable pharmaceuticals arena. Actavis has set its sights firmly on the hospital sector and currently has around 300 pending applications worldwide for injectable medicines. Furthermore, Actavis' ambitious pipeline comprises more than 60 new injectable projects, developed both internally and through established relationships with other developers."

Actavis currently markets over 50 hospital products worldwide, with a focus on oncology products and a growing range of anti-infectives, local anesthetics and analgesics.

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

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 Group
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