Actavis Inc. Reintroduces Oxycodone.Little Falls Little Falls is the name of some places in the United States of America:
abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval of critical pain solution MORRISTOWN, N.J. -- Actavis Inc. today announced the reintroduction by its Actavis Totowa subsidiary of Oxycodone oxycodone /oxy·co·done/ (-ko´don) an opioid analgesic derived from morphine; used in the form of the hydrochloride and terephthalate salts. ox·y·co·done n. 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 A settlement of a lawsuit or criminal case in which a person or company agrees to take specific actions without admitting fault or guilt for the situation that led to the lawsuit. A consent decree is a settlement that is contained in a court order. of Permanent Injunction permanent injunction n. a final order of a court that a person or entity refrain from certain activities permanently or take certain actions (usually to correct a nuisance) until completed. with the Food and Drug Administration (FDA) regarding the company's Actavis Totowa LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control 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 This term is often used in law as equivalent to mentioned specifically, designated, or expressly named or granted; as in speaking of enumerated governmental powers, items of property, or articles in a tariff schedule. requirements that demonstrate compliance with FDA's current good manufacturing practice Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. (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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. , 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. Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5942519&lang=en |
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