Reuters: Regulatory News: UPDATE 2-Affiliate of US meningitis-linked firm extends shutdown

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UPDATE 2-Affiliate of US meningitis-linked firm extends shutdown Nov 2nd 2012, 19:06 Fri Nov 2, 2012 3:06pm EDT By Toni Clarke Nov 2 (Reuters) - Ameridose LLC, sister company to the pharmacy at the heart of a meningitis outbreak in the United States, has agreed to extend its closure by two weeks while state and federal investigators continue to examine its facilities. The company's accord, with Massachusetts regulators on Friday, will keep it closed until Nov. 19, according to the agreement, a copy of which was obtained by Reuters. Ameridose has the same owners as the New England Compounding Center (NECC), which distributed a tainted steroid used for back pain that has killed 28 people in the meningitis outbreak. On Thursday, the U.S. Centers for Disease Control and Prevention said the toll was revised down from 29 deaths. Two days ago, Ameridose issued a voluntary recall of all its products following a U.S. Food and Drug Administration directive to improve its sterility testing process. Westborough, Massachusetts-based Ameridose closed on Oct. 10. It said on Wednesday that it had not received any reports of adverse reactions to the drugs it is recalling. NECC's injectable steroids turned out to be contaminated with fungus and as of Thursday, were blamed for 377 cases of fungal meningitis. The FDA has said it is in contact with other manufacturers about filling the supply gap left by the shutdown of Ameridose, which makes and ships sterile injectable drugs. In a blog post on Friday, FDA Commissioner Dr. Margaret Hamburg said the agency has identified a number of Ameridose products, including drugs used during surgery and to treat conditions that include congestive heart failure, that were on the current drug shortages list before the recall. "We also know that the supply of other drugs may be affected by the Ameridose recall," she said. "FDA is doing everything we can to minimize the impact this recall may have on current drug shortages, and to prevent other shortages from occurring." Link this Share this Digg this Email Reprints

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