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news.Sucampo Pharma Europe has received notice that all of the marketing authorization applications for lubiprostone, 24mcg, for the indication of chronic idiopathic constipation in adults have been received and validated by the individual regulatory agencies in Belgium, Denmark, France, Germany, Ireland, the Netherlands, Spain, Sweden and the UK.
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The applications were submitted using the decentralized process with the UK serving as the reference member state. With the validation, the agencies will begin their formal review of the applications.
These applications represent the first major marketing authorization effort for Sucampo Pharmaceuticals outside the US. Sucampo Pharmaceuticals continues to review marketing opportunities in other parts of the world in order to build upon the current success of lubiprostone (Amitiza) in the US.
Sucampo Pharma Europe is a wholly-owned European subsidiary of Sucampo Pharmaceuticals.