Italian drugmaker Cosmo Pharmaceuticals, which is primarily focused on the optimization of therapies for gastrointestinal disorders, says that regulators in 15 European Union states have agreed the core labeling information in Marketing Autorization Applications for an ulcerative colitis drug developed using its formulation technology.
The drug in question Mesavancol/ Mesavancol (MMX mesalazine) was developed under license in a collaboration between fellow Italian pharmaceutical firm Giuliani's Mesavancol and UK company Shire. Earlier this year Cosmo received US Food and Drug Administration approval for an automated production plant that will be used to manufacture Mezavant for the US market.
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