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Epogen Counterfeits: Amgen Not Liable For Drug Out Of Its Control, Court Says

Executive Summary

Amgen cannot be held responsible for diluted vials of Epogen appearing on the market because the product had left the company's control, a federal court ruled

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AstraZeneca Will Comply With The Spirit Of A Drug Import Law

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Anti-Counterfeiting Interim Step Should Be Paper Pedigree, PhRMA Says

Drug products should contain paper pedigrees as an interim anti-counterfeit measure, the Pharmaceutical Research & Manufacturers of America said at FDA's Oct. 15 Anti-Counterfeit Drug Initiative public meeting in Bethesda, Md

Counterfeit drugs

Serono's Serostim (somatropin) lot number (S810-1A1) found to contain counterfeit versions of the AIDS wasting drug, Serono announced May 16. GlaxoSmithKline reported two Ziagen (abacavir) bottles with counterfeit Combivir (lamivudine/zidovudine) labels in a May 10 "Dear Health Care Professional" letter. Two other Combivir labels are "suspect," the company said. Amgen reports counterfeit Epogen (epoetin alfa) vials containing diluted drug in May 8 letter. The unusual cluster of public counterfeiting reports, including Lilly's Zyprexa (1"The Pink Sheet" May 13, In Brief), may help the industry combat proposed reimportation legislation...





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