NEWS | Wednesday, 12 March 2008

Actavis receives FDA approval for Irinotecan Hydrochloride Injection

Actavis Group, the international generic pharmaceuticals company, said it had received approval for Irinotecan Hydrochloride Injection from the US Food & Drug Administration (FDA). Distribution of the product would commence immediately, the company said in a statement recently.
Irinotecan Hydrochloride Injection, the generic equivalent to Pfizer’s Camptosar, will be available in 40 mg/2 ml and 100 mg/5 ml vials 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 12 months ending December 2007 according to IMS Health data.
Doug Boothe, Executive Vice President of US Commercial and 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 projects, developed both internally and through established relationships with other developers.”
Actavis already markets over 50 hospital products worldwide, 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 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. More information about Actavis can be found at www.actavis.com