Statement From Novo Nordisk Regarding the Petition to the FDA By Public Citizen
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.
Posted: April 2012