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Managed Care Business Week

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Danco Laboratories, LLC



Company announces updated labeling for Mifeprex



August 16th, 2005

Danco Laboratories announced that it is modifying the labeling for Mifeprex to include updated safety information.

Mifeprex has been available in the U.S. for almost 5 years, and more than 460,000 women in this country have chosen it for early abortion since U.S. Food and Drug Administration (FDA) approval in Septembe, 2000.

During that time period, Danco has received reports of 5 deaths from serious bacterial infection and sepsis following treatment with Mifeprex and misoprostol.

"All of these cases had atypical presentations of infection, and in the first three cases, the bacteria were identified as a very rare anaerobic,...


Source: Managed Care Business Week (2005-08-16)

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