FDA Delays Novo Diabetes Drugs Over Heart Risks

Law360, New York (February 11, 2013, 2:14 PM EST) -- The U.S. Food and Drug Administration will require an additional clinical trial before approving Novo Nordisk A/S’ proposed diabetes treatments Tresiba and Ryzodeg, the company announced Sunday, amid concerns about an increased risk of heart attack from the drugs.

According to Novo’s announcement, the FDA has asked the company for clinical information from an additional dedicated cardiovascular trial on the drugs before it will consider approving the treatments. The need for a trial will likely push the approval schedule for the drugs into at least 2014,...
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