FILE - This April 20, 2010, file photo shows an exterior view of Amgen offices in Fremont, Calif. Amgen Inc. agreed on Tuesday, Dec. 18, 2012, to pay $762 million to resolve federal litigation accusing the drugmaker of marketing the anemia treatment Aranesp for unapproved uses. (AP Photo/Paul Sakuma, File)
News Summary: Regulators want more on Novo drugs
Published: 04:25:06 PM, Mon 11 February 2013 UTC
ANOTHER STUDY: Danish drugmaker Novo Nordisk said that U.S. regulators need to see data from a new study that evaluates cardiovascular health before they can finish reviewing the diabetes treatments Tresiba and Ryzodeg for approval.
THE CONSEQUENCE: Novo Nordisk submitted the drugs for U.S. approval in September 2011. Another study could delay a decision from the U.S. Food and Drug Administration for several years.
THE DRUGS: Tresiba and Ryzodeg both use the long-acting insulin degludec, which can help diabetics control their blood sugar levels beyond the 24-hour period offered by current products on the market. European regulators approved the drugs last month.
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