Actavis Inc. Reintroduces Oxycodone

Little Falls facility resumes production with FDA approval of critical pain solution

MORRISTOWN, N.J.--()--Actavis Inc. today announced the reintroduction by its Actavis Totowa subsidiary 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. 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: 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 Inc. “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. “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.”

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. Based in Iceland, the company has operations in 40 countries, with more than 10,000 employees.

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Contacts

Media Line for Actavis U.S.
Tel: (973) 889-6689
E-mail: media@actavis.com
or
Actavis Group
Hjördís Árnadóttir
Director – External Communications
Tel: (+354) 535 2300 / 840 7476
E-mail: harnadottir@actavis.com

Actavis reintroduces Oxycodone 15 mg and 30 mg tablets (Photo: Business Wire)

Actavis reintroduces Oxycodone 15 mg and 30 mg tablets (Photo: Business Wire)

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Contacts

Media Line for Actavis U.S.
Tel: (973) 889-6689
E-mail: media@actavis.com
or
Actavis Group
Hjördís Árnadóttir
Director – External Communications
Tel: (+354) 535 2300 / 840 7476
E-mail: harnadottir@actavis.com