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March 14, 2014
17:33 EDTSCMP, TKPYYSucampo, Takeda say that Amitiza NDA will not be filed in second half of 2014
Sucampo Pharma Americas, a wholly owned subsidiary of Sucampo Pharmaceuticals (SCMP), and its development and commercialization partner's subsidiary Takeda Pharmaceuticals (TKPYY) announced that the New Drug Application, NDA, for the liquid formulation of Amitiza will not be filed in the second half of 2014. In preliminary pre-NDA meeting comments, the FDA informed Sucampo that it would require additional data to characterize pharmacokinetics of the new formulation. As a result of this outcome in conjunction with the FDA feedback, Sucampo and Takeda are now assessing next steps, which may include formulation modification.
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July 22, 2014
15:12 EDTSCMPSucampo says FDA approves addition of Nitto Medic as Rescula production site
Sucampo Pharmaceuticals disclosed in a regulatory filing that on July 15 the company received an approval letter from the FDA to its prior approval supplement in response to FDAs review of the revised Drug Master File of R-Tech Ueno. The approval provides for the addition of Nitto Medic of Toyama, Japan as a new production site for Rescula 0.15%. "The company has adequate supply of RESCULA to be able to supply the U.S. market into the first quarter of 2015," Sucampo added.
July 21, 2014
15:10 EDTTKPYYTakeda Pharmaceutical unit granted orphan status for gastric cancer treatment
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