US FDA BANS COPIED ZALCITABINE

17 February 1992

The US Food and Drug Administra-tion has banned the sale of an unauthorized copy of Hoffmann-La Roche's AIDS therapy Hivid (zalcitabine; ddc) following tests which found "potentially serious variations in product potency and quality."

The counterfeit antiviral product has been used by between 8,000 and 10,000 AIDS patients who did not qualify for it under Roche-sponsored programs.

Last week the Wall Street Journal noted that patients were able to obtain copied zalcitabine to last for about a month for about $50. But following FDA tests, samples were found to contain a range of doses, including no drug or twice the labelled amount.

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