Novo Nordisk, the Danish drug company that has a manufacturing facility in Clayton, announced Sunday that federal regulators have denied approval of its insulin drug Tresiba.

The announcement sent Novo Nordisk shares tumbling Monday morning.

The Copenhagen-based company said it received on Friday a Complete Response Letter from the Food and Drug Administration, which is what the agency issues when its review process is complete and a drug application is not ready for approval.

The FDA is requesting additional data to evaluate the drugs' potential cardiovascular risks.

Novo Nordisk will expand its Clayton plant and add 85 jobs by 2015.

The Danish drug maker will receive incentives worth as much as $7.1 million from the state and Johnston County if it meets its hiring goals.

The new jobs will pay average annual salaries of $42,976, above the Johnston County average of $31,408, state officials announced this morning.

One of Novo Nordisk's suppliers, Nypro, also will expand its factory outside Asheville and create 156 jobs, including 120 related to its work for Novo Nordisk. 

N.C. Commerce officials said today that Novo Nordisk, the Danish drug maker with an insulin plant outside Clayton, failed to meet its job creation requirements for 2008 and 2009.

Novo Nordisk was awarded state incentives worth $2.3 million in 2004 if the company met its hiring goals and retained its existing employees.

After receiving $129,750 in incentives in 2005 and 2006, Novo Nordisk has not qualified for any payments the last three years.

Commerce officials said today that the company partially blamed the economic downturn for the lack of new hires. Novo Nordisk did not immediately return a call seeking comment.

Novo Nordisk has created 82 jobs to date, below the 168 its was expected to add by the end of 2009. The new jobs did meet the state's wage requirements with an average annual salary of $52,000.

For the second time this week, federal regulators are warning consumers not to use stolen medical products that were made in the Triangle.

The U.S. Food and Drug Administration issued a reminder today regarding 129,000 vials of the insulin Levemir, made by Novo Nordisk at its Clayton plant. The vials were stolen earlier this year in North Carolina during shipping but only about 2 percent have been recovered, the FDA reports.

The stolen insulin may not have been stored and handled properly and could be dangerous for patients, the FDA said.