Little Falls facility resumes production with FDA approval of critical pain solution
Reykjavik, Iceland, 17 April 2009 — Actavis Group, the international generic pharmaceuticals company, today announced the reintroduction by its subsidiary in the United States of Oxycodone 15 mg and 30 mg tablet products to pharmacies and customers. Oxycodone is the first product to be manufactured at Actavis’ Little Falls, NJ facility following a recently completed FDA inspection.
In December 2008, Actavis Inc. in the US announced that it reached agreement on a Consent Decree of Permanent Injunction with the Food and Drug Administration (FDA) regarding the company’s Actavis Totowa LLC subsidiary. This Decree only impacted operations at Actavis Totowa’s three facilities in the US: two in Totowa, NJ and one in Little Falls, NJ.
Actavis agreed to not distribute any products from the Actavis Totowa facilities until it certified completion of certain enumerated requirements that demonstrate compliance with FDA’s current good manufacturing practice (cGMP) and has passed follow-up FDA inspections of the facilities.
“Through an extensive process, Actavis re-qualified all equipment and utilities for production and packaging – and we re-qualified and revalidated all methods used to release products from our Totowa facilities,” said Nasrat Hakim, Vice President of Quality Compliance and Technical Services for Actavis. “This is a very positive step and took incredible team work. The next step in the process will involve additional interaction with the FDA so that we can continue to introduce products as outlined in the Consent Decree.”
The FDA completed its inspection and approved the release of the first two products as outlined in the Decree: Oxycodone 15 mg and 30 mg tablets. Subsequent inspections, also as outlined in the Decree, will follow.
“Our customers come first,” said Doug Boothe, CEO of Actavis Inc. in the US. “We are sorry for the inconvenience the recall caused for some but as a company, we are committed to producing high quality pharmaceuticals, and that’s what we will continue to do.”
Actavis, a leading manufacturer of generic pharmaceuticals, announced a voluntary product recall in August 2008 after determining that three of its facilities did not meet the highest standards for quality manufacturing. Following the recall, the company enacted a comprehensive remediation program and engaged an outside firm to assess Actavis Totowa facilities.
“Our long and successful history with Oxycodone made it the right medication to produce first,” added Boothe. “It is one of the many quality products that Actavis will have back on the market in the coming months and we are pleased that our customers have responded so positively to its reintroduction.”
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About Actavis Inc.
Actavis Inc. is the U.S. subsidiary of Actavis Group hf. Approximately one quarter of Actavis’ sales are generated in North America, Actavis’ single largest market. Based in Morristown, NJ, Actavis has U.S. manufacturing facilities in Elizabeth, NJ; Little Falls, NJ; Totowa, NJ; and Lincolnton, NC. Actavis also has a research and development facility in Sunrise, FL and a packaging facility in Totowa, NJ. For more information, please visit www.actavis.us
About Actavis Group
Actavis is one of the world’s leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. The company has operations in 40 countries, with more than 10,000 employees. For more information, please visit www.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.
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