Novo Nordisk, Inc. will pay $25 million to settle a whistleblower lawsuit that involved the illegal off-label marketing of hemostasis management drug, NovoSeven. Once approved by the FDA, a manufacturer may not market or promote a drug for any use not specified in its new drug application and approved by the FDA. Such unapproved uses are also known as ‘off-label’ uses. The qui tam relators or “whistleblowers” alerted the federal and state governments to the fraud.
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