Product News and Recalls

FDA says Januvia ‘misbranded’ because of late study

A report on the blog Pharmalot says the U.S. Food and Drug Administration has ruled that pharmaceutical company Merck was nearly two years late with a mandated study of its Januvia and Janument diabetes medications.

The FDA had instructed to Merck to conduct a post-marketing study after the agency revised prescribing information for the drugs in 2009 to include 88 cases of acute pancreatitis between 2006 and 2009.

A subsequent study linked Januvia and another diabetes drug, Byetta, with a higher risk of pancreatitis and pancreatic cancer. In addition, researchers in the latter study found that Byetta may carry an increased risk of thyroid cancer.

In October of 2009, the FDA sent Merck a letter stating that a three-month pancreatic safety study of the drug would be required as a condition for supplemental new drug approvals.

The company was required to submit a final protocol by June 15, 2010; complete the study by March 15, 2011, and submit a final report by June 15, 2011.

But in February of this year, the FDA sent Merck a letter informing the company that it was 20 months late. Merck also proposed to satisfy the post-marketing requirement by submitting study data from another independently conducted investigator-initiated study, not the agreed-upon studies cited by the FDA, and still missed deadlines.

The FDA letter said Januvia and Janument were classified as “misbranded.” The report also says the FDA could levy a $250,000 fine for each violation.

See the story here: