Novo Nordisk's Insulin Drug Application Accepted by FDA
April 08 2015 - 1:38AM
Dow Jones News
By Dominic Chopping
Danish pharmaceutical company Novo Nordisk A/S (NOV) said late
Tuesday the U.S. Food and Drug Administration (FDA) has accepted a
resubmitted application for insulin drugs Tresiba and Ryzodeg.
To preserve the integrity of the ongoing trial, only a small
team within Novo Nordisk has access to the data, it said. This team
has prepared the interim analysis for the resubmission and will
interact with the FDA during the review.
It said Novo Nordisk management does not have access to the
results of the interim analysis.
The trial is expected to be completed in the second half of
2016.
-Write to Dominic Chopping at dominic.chopping@wsj.com; Twitter:
@WSJNordics
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
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