Novo Nordisk announces conclusion of U.S. federal investigation of marketing practices

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Sep 05, 2017, 17:10 ET

PLAINSBORO, N.J., Sept. 5, 2017 /PRNewswire/ -- Today, Novo Nordisk announced it has reached a resolution with the U.S. federal government and the states about an investigation launched in February 2011 concerning sales and marketing practices for Victoza^®, a medicine used to treat type 2 diabetes. The investigation was disclosed by Novo Nordisk for the first time in a company announcement on February 16, 2011.

The settlement resolves claims alleging Novo Nordisk did not fully comply with communicating safety information based on a U.S. Food and Drug Administration (FDA)-approved Risk Evaluation and Mitigation Strategy (REMS) for Victoza^®. Under the terms of the settlement agreement, Novo Nordisk will pay approximately $46.5 million to the federal government and to states that reimbursed for Victoza^® under their Medicaid programs. Additionally, Novo Nordisk will pay $12.15 million to resolve a complaint filed by the government on behalf of the FDA in federal court. In connection with this settlement, the Company has also resolved several private whistle-blower cases related to the government's investigation. The U.S. Department of Health & Human Services, Office of Inspector General, determined that it would not seek a Corporate Integrity Agreement as part of this settlement.

"At Novo Nordisk, we take our responsibility to communicate the safety and clinical benefits of our medicines seriously, and remain committed to properly addressing safety questions healthcare professionals ask every day," said Doug Langa, Executive Vice President, Head of North America Operations and President of Novo Nordisk Inc. "Our focus will always be to ensure that those caring for patients have the data they need to make the most informed treatment decision. While we do not agree with the U.S. government's legal conclusions and deny any wrongdoing, we're pleased to have negotiated a resolution that allows the company to return its full attention to developing medicines that help improve the lives of patients."

About Novo Nordisk
Novo Nordisk is a global health care company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.

SOURCE Novo Nordisk