FDA Staff Recommends Study Of Abbott Seizure Drug

Law360, New York (June 19, 2009, 12:00 AM EDT) -- U.S. Food and Drug Administration staff is recommending that an Abbott Laboratories drug used to treat seizure disorders undergo additional studies to determine its potential impact on children's development.

The FDA released the memo on its Web site Friday, ahead of a Tuesday meeting by the agency's pediatric advisory panel, which will be reviewing several drugs and their potential adverse effects.

The memo summarized the post-marketing adverse events reports associated with the use of anti-seizure drug Depakote in pediatric patients up to 16 years of age....
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