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FDA awaits Actavis permanent injunction
January 16th, 2009 by Emily Marsh
The drug company Actavis, producer of the heart drug Digitek, agreed to close several plants in New Jersey and will not resume operations at these plants until U.S. standards for testing and manufacturing have been met by the FDA. According to Pharma Tech Live, the FDA has filed a consent degree, banning Actavis from distributing drugs in Totowa and Little Falls, N.J. The agreement also gives the FDA the right to close the plants if violations persist and to fine the company $15,000 a day afterward.
The FDA filed an action against Actavis Dec. 23, which was signed by Actavis on Dec. 29. The FDA awaits a permanent injunction against this company. The FDA declares Actavis and its officers have been manufacturing and distributing “unapproved” drugs in the U.S. The FDA promotes pharmacists to stop dispensing unapproved Digitek drugs. The FDA strongly encourages Digitek consumers to discuss alternative plans with their doctors.
Janet Woodcock, director of FDA’s center for Drug Evaluation and research, stated, “The FDA will not allow manufacturers to put the public’s health at risk. These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”
John LaRocca, Actavis’s chief legal officer, said, “We have been working with the FDA to address compliance issues at the Totowa facilities. We have an entirely new management team in place at Little Falls, [New Jersey], and have invested significantly to reinforce systems and procedures intended to better ensure robust, sustainable compliance. This agreement with the agency is a positive step and is one we have looked forward to reaching. We will continue to work with the FDA to show that we have addressed all of the agency’s compliance and manufacturing issues.”
