› $4.85 Billion settlement in drug case
Actavis Inc. has signed a proposed consent decree agreeing to fix the manufacturing problems at its New Jersey plant where it produced and sold the heart drug, Digitek, a brand of digoxin, according to the Canadian Medical Association Journal.
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.
U.S. Attorneys in New Jersey are moving to close three Actavis Inc. plants, the company that manufactures Digitek, until they comply with FDA regulations.
On October 8, John Dingell (D-MI), chairman of the U.S. House Committee on Energy and Commerce, and Bart Stupak (D-MI), chairman of that committee’s Subcommittee on Oversight and Investigations, wrote a letter to the U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach to request more information concerning the FDA’s procedure for examining manufacturing facilities of the generic drug manufacturer Actavis after several of the company’s products were recalled.
Actavis Totowa, the drug manufacturer of Digitek, just announced a voluntary recall, to the retail level, of more than 65 generic drug products manufactured at its Little Falls, New Jersey, facility, according to a release on the company web site. This recall follows an inspection conducted by the Food & Drug Administration, earlier this year, which revealed that operations at the New Jersey facility did not meet FDA standards.
