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Novartis Pharmaceuticals.(DDMAC)
- Article from:
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Warning Letter Bulletin
- Article date:
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June 1, 2008
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Copyright informationCOPYRIGHT 2008 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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East Hanover, NJ, May 1 (DDMAC)
FDA deemed a Partial Seizure Lenticular Magnet for Trileptal (oxcarbazepine) Tablets and Oral Suspension violative "because it omits the full indication for Trileptal and omits information about the risks associated with its use" and thus misbrands the drug. "These violations are concerning from a public health perspective because they may encourage the use of Trileptal in circumstances other than those for which the drug has been shown to be safe and effective, and suggest that Trileptal is safer and more effective than has been demonstrated," the agency wrote.
The INDICATIONS AND USAGE section of the approved product labeling (PI) for ...