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Information - Department of Justice - justice 2025

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The document is a legal information charging Novartis Pharmaceuticals Corporation with criminal violations related to the distribution of misbranded drugs, specifically Trileptal, an anti-epileptic medication. It outlines how Novartis unlawfully promoted Trileptal for off-label uses, such as treating bipolar disorder and neuropathic pain, without FDA approval. The document details the implications of these actions, including potential harm to patients and financial gains for the company, and includes a notice of forfeiture for the misbranded drug.

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Click ‘Get Form’ to open it in the editor.
Begin by filling in the 'Criminal No.' and 'Date Filed' sections at the top of the form. These fields are essential for identifying your case.
In the 'Violation' section, accurately enter the relevant U.S. Code citations pertaining to the charges against you.
Proceed to complete each numbered paragraph under 'Information COUNT ONE'. Ensure that all details about the defendant, drug distribution, and FDA approvals are clearly stated.
For sections detailing off-label promotion and harm caused, provide comprehensive information based on your knowledge or documentation available.
Finally, review all entries for accuracy before saving or submitting your completed form through our platform.

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