Drug news
Dutch regulatory authority rejects Cortiment (Cosmo/Ferring) for Ulcerative Colitis
Cosmo Pharmaceuticals received a communication from the Dutch Regulatory Agency (MEB) declining the approval of Cortiment(budesonide with MMX technology), indi�ca�ted for the induction of remission in patients with active, mild to moderate Ulce�ra�tive Colitis. The reasons given for the decline were on the grounds of clinical relevance. Cosmo is awaiting the formal letter to get full disclosure of the reasons for this decision. Santarus has filed the drug as Uceris at the FDA. Ferring have ROW rights licensed from Cosmo except for the US and Japan.
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