FDA Letters To AstraZeneca And Novo Nordisk Approve Addition Of Information About Increased Risk For Medullary Thyroid Carcinoma (MTC)
The diabetes drugs Bydureon (exenatide extended-release) for injectable suspension and Victoza (liraglutide [rDNA origin]) injection) were the subject of March 2015 FDA letters concerning the supplemental approval about labeling revisions.
We also refer to our letter dated October 7, 2014, notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we believe should be included in the labeling for long-acting GLP-1 receptor agonist products. This information pertains to the risk of medullary thyroid carcinoma.
Strictly Confidential, No Obligation.
In both AstraZeneca's Bydureon Prescribing Information and Novo Nordisk's Victoza Prescribing Information, the March 2015 label revisions concerning medullary thyroid carcinoma (MTC) can be seen in the so-called "Black Box" warning at the beginning of that document as well as at part 5.1 Risk of Thyroid C-cell Tumors in the Warnings and Precautions section.
As you may know, these diabetes drugs, Bydureon and Victoza, are alleged to have caused thyroid cancer and pancreatic cancer in drug injury lawsuits filed against the responsible pharmaceutical companies.
We will continue to watch for further developments about the safety profile of Bydureon and Victoza from the FDA or other drug regulatory agencies around the globe.