SOURCE: Actavis

March 14, 2008 10:19 ET

FDA Gives Go Ahead for Actavis' Irinotecan Hydrochloride Injection

Generic Pharmaceuticals Company Actavis Will Begin Immediate Distribution of Its First Injectable Product in the US

MORRISTOWN, NJ--(Marketwire - March 14, 2008) - Actavis Group, the international generic pharmaceuticals company, has received approval for Irinotecan Hydrochloride Injection, a cancer drug, from the US Food & Drug Administration (FDA).

Irinotecan Hydrochloride Injection, the generic equivalent to Pfizer's Camptosar®, is used to treat patients with metastatic carcinoma of the colon or rectum. Annual sales of the drug in the US amounted to approximately US$556 million for the 12 months ending December 2007 according to IMS Health data.

"The launch of Irinotecan marks the expansion of Actavis' US portfolio into the injectable pharmaceuticals arena," said Doug Boothe, Executive Vice President of US Commercial & Administration.

"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 projects, developed both internally and through established relationships with other developers," he added.

Actavis already markets over 50 hospital products around the world, with a focus on oncology products and a growing range of anti-infectives, local anaesthetics and analgesics.

Actavis is one of the world's leading pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. Based in Iceland, the company has operations in 40 countries with 11,000 employees.

Visit the Actavis website for more information on Irinotecan Hydrochloride Injection and other Actavis generic pharmaceuticals -- www.actavis.com.

About Actavis Group

Actavis is one of the world's leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. Based in Iceland, the company has operations in 40 countries, with 11,000 employees.

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.

Contact Information

  • Contact:
    Actavis Group
    Hjordis Arnadottir
    Director, External Communications
    Tel: (+354) 535 2300 / (+354) 840 7476
    E-mail: Email Contact