Statement from Novo Nordisk regarding the petition to the FDA by Public Citizen (20 April 2012)
20 April 2012. Yesterday, Public Citizen, a US-based consumer advocacy organisation filed a petition calling on the FDA to remove Novo Nordisk’s diabetes medicine Victoza® from the US market. In response, Novo Nordisk‘s US affiliate, Novo Nordisk Inc, issued the following statement:
Novo Nordisk is committed to patient safety and rejects Public Citizen’s assertion that the benefits of Victoza are outweighed by its risks.
When it approved Victoza® two years ago, the FDA had before it a large amount of data, including clinical trials in nearly 4,000 patients. As part of its usual process, it carefully assessed all of the data and approved Victoza® with labeling that informs physicians and people with diabetes about the appropriate use of the product.
In the two years since Victoza® was approved, Novo Nordisk has continued to work closely with the FDA and the medical community to monitor the benefits and appropriate use of Victoza®. Our experience in those two years does not support the Public Citizen call to deprive patients of the benefits of Victoza®. Indeed, the FDA just recently approved the expanded use of Victoza®.
Novo Nordisk wants to assure patients taking Victoza® and healthcare professionals that they should remain confident in its safety.