ARTICLE | Clinical News

Cortiment budesonide MMX regulatory update

August 13, 2012 7:00 AM UTC

Cosmo said the Netherlands Medicines Evaluation Board (MEB) decided not to approve an MAA for Cortiment budesonide to treat active, mild to moderate ulcerative colitis. Cosmo said MEB based its decision on "clinical relevance," but the company is waiting to receive the formal letter from MEB before providing details about the decision. Cosmo did say it is considering options for an appeal. The MAA was submitted under the EU's decentralized procedure, with the Netherlands acting as the reference member state. ...