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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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August 9, 2014
15:22 EDTTKPYYMillennium gets FDA approval for Velcade for retreatment of multiple myeloma
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