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Novartis Pharmaceuticals.

Publication: Warning Letter Bulletin
Publication Date: 01-JUN-08
Format: Online
Delivery: Immediate Online Access
Full Article Title: Novartis Pharmaceuticals.(DDMAC)

Article Excerpt
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...

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