Janssen submits applications seeking approval of Stelara in United States and European Union for Crohn's disease

30 November 2015 - Janssen Biotech, Inc. and Janssen-Cilag International NV (Janssen) announced today the submission of a Biologics License Application to the U.S. FDA and a Grouped Type II Variation/Extension Application to the EMA seeking approval of Stelara (ustekinumab) for the treatment of adult patients with moderately to severely active Crohn’s disease.

For more details, go to: http://www.janssen.com/janssen-submits-applications-seeking-approval-stelara-united-states-and-european-union-crohn-s

Michael Wonder

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Michael Wonder

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Medicine , Europe , US , Submission