FDA Says GSK Drug Manufacturing Not Up to Snuff
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The Food and Drug Administration (FDA) and the Department of Justice today initiated seizures of Paxil CR and Avandamet tablets manufactured by GlaxoSmithKline, Inc. (GSK), citing ongoing concerns about manufacturing quality. Manufacturing practices for the two drugs — approved to treat depression and panic disorder (Paxil CR), and Type II Diabetes (Avandamet) — have failed to meet FDA standards for product safety, strength, quality and purity, the agency says. “FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing,” says John M. Taylor, FDA Associate Commissioner for Regulatory Affairs, in a statement. “Once we discover a company is not following the standards, which were created to ensure safety and quality, we expect them to correct the deficiencies in an expedited manner,” he added. More : health.dailynewscentral.com |