March 26, 2018 / 1:48 PM / 3 months ago

BRIEF-Novo Nordisk: FDA Approves Update to Tresiba Label to Include Devote data

* U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS APPROVED AN UPDATE TO US PRESCRIBING INFORMATION FOR TRESIBA (INSULIN DEGLUDEC) TO INCLUDE DATA FROM THE DEVOTE TRIAL​

* ‍FOLLOWING INTERACTIONS WITH FDA, NOVO NORDISK HAS WITHDRAWN APPLICATIONS RELATED TO DATA FROM SWITCH TRIALS​

* ‍”VERY PLEASED THAT FDA HAS APPROVED UPDATED LABEL FOR TRESIBA AS ONLY BASAL INSULIN TO BE LABELLED WITH A LOWER RATE OF SEVERE HYPOGLYCAEMIA COMPARED TO INSULIN GLARGINE U100,” SAYS CSO MADS KROGSGAARD THOMSEN​ Source text for Eikon: Further company coverage: (Copenhagen newsroom)

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