Regulatory Issues

FDA accuses maker of antiretroviral of misleading promotions

Published in AIDS Weekly, July 5th, 2004

The U.S. Food and Drug Administration (FDA) has accused Abbott Laboratories, Inc., of providing the public with misleading information about a drug used to treat HIV infection, saying the promotional materials raised health and safety concerns.

In a letter sent to Abbott, the FDA said a comparative-cost chart for the Norvir soft gelatin capsules was "false and misleading" because it claims the drug has the lowest daily cost of all antiretrovirals.

The FDA said the chart also improperly implied Norvir might be used alone in some cases - when its instructions say it is for use in small doses to boost the potency of AIDS combination-drug...

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Source: AIDS Weekly (2004-07-05)

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