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Abbott Laboratories Hit With Fine For Drug Label Mishap

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Abbott Laboratories Hit With Fine For Drug Label Mishap

Company Fined For Uses Not On Label

The importance of having an accurate and proper product label cannot be overstated, especially when considering the consequences of mislabeling, which Abbott Laboratories can attest to.

The U.S. pharmaceutical giant was recently directed to pay $700 million in fines relating to a guilty plea it submitted in connection to a charge that the company promoted the drug Depakote for uses not authorized by the Food and Drug Administration. Abbott was ordered by a federal judge in Virginia to pay $500 million in criminal fines, a forfeiture of $198.5 million and $1.5 million to the Virginia Medical Fraud Control Unit.

Correct Labels Needed To Guarantee Compliance
Having a label that is in clear accordance to any laws or regulations on accepted use is the best way for businesses to ensure compliance. But in Abbott's case, the company implicated itself by promoting off-label uses and ignoring the accepted ones.

Also part of the judgment was a five-year probationary period for marketing Depakote as a treatment for behavioral disturbances in dementia patients from 1998 to 2006, and schizophrenia from 2002 to 2006.