The FDA approved Victoza based on five clinical trials involving more than 3,900 people. In those trials, pancreatitis (inflammation of the pancreas) occurred more often in patients who took Victoza than in patients taking other diabetes medicines. The FDA said it was requiring the company to conduct a post-approval study to test Victoza's cardiovascular safety in a higher-risk group of patients. No increase in heart problems was seen in the mainly low-risk patients in clinical trials.
FDA approval allows Victoza to be used in the U.S. in monotherapy, as a second-line treatment, and in combination with oral diabetes drugs. Victoza is made by the drug company Novo Nordisk. The launch price of the 1.2-milligram dose will be $8.03 a day. In America about 23.6 million people are diabetes and the news about Victoza could bring happiness on their faces.
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