Published in Medical Letter on the CDC and FDA, December 14th, 2003
This decision is based on results from an animal toxicology study that showed liver abnormalities after a 9-month exposure to pralnacasan at high doses. There have been no significant adverse events associated with liver toxicity in subjects and patients who participated in pralnacasan studies to date.
The decision was confirmed following a discussion with the Food and Drug Administration (FDA) that Aventis and Vertex had...
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