Glaxo agrees to $750 mil. settlement: A whistleblower suit alleging microbial contamination in products including nonprescription anti-infective ointment Bactroban (mupirocin) and an H2 blocker available OTC, Tagamet (cimetidine), and other good manufacturing practice violations at GlaxoSmithKline's former Cidra, Puerto Rico, manufacturing plant leads to a $750 million settlement with the Department of Justice, the New York Times reports here. "The Pink Sheet" DAILY reports here the settlement is the fourth largest amount ever paid by a pharmaceutical firm to the U.S. to resolve criminal and civil allegations relating to the manufacturing and sale of adulterated drugs.
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Bayer pays states $3.3 mil. in health claim litigation: Bayer cut claims that links selenium in its One A Day Men's multivitamins to a reduced risk of prostate cancer before a likely FDA action, but still must pay California, Illinois and Oregon $3.3 million to settle a complaint accusing the firm of “deceptively leveraging fear of prostate cancer” to market the product. The Center for Science in the Public Interest, which noted the prostate claims and filed a separate suit against Bayer, comments here on the settlement, and "The Tan Sheet" reports here on Bayer's June 2009 decision to back off the claim as indications grew that FDA was ramping up enforcement against unsubstantiated health claims.
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GSK, McNeil present at NRT workshop: GlaxoSmithKline and McNeil Consumer Healthcare OTC executives are among industry representatives and researchers making presentations at FDA's Oct. 26-27 workshop in Arlington, Va., that will influence whether the agency expands the indication for nicotine-replacement therapy use beyond the current 12 weeks. We reported here in "Health News Daily" that the Center for Drug Evaluation and Research organized the workshop to explore the long-term safety of nicotine based on animal and human studies, addiction to NRTs and evidence NRTs help with abstinence or reduced smoking levels.
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-- Malcolm Spicer (email@example.com)