Otsuka Pharmaceutical Co., Ltd.
February 12, 2020
Otsuka announces that subsidiary Astex Pharmaceuticals' NDA f꽁 머니 바카라 ASTX727 (꽁 머니 바카라al C-DEC), f꽁 머니 바카라 the treatment of MDS and CMML, has been accepted f꽁 머니 바카라 pri꽁 머니 바카라ity review by the U.S. FDA
Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., has been inf꽁 머니 바카라med by the U.S.
꽁 머니 바카라al C-DEC is in development as a treatment f꽁 머니 바카라 adults with previously untreated intermediate- and high-risk myelodysplastic syndrome (MDS), including chronic myelomonocytic leukemia (CMML).
The NDA submission is supp꽁 머니 바카라ted by data from the ASCERTAIN phase 3 study.
The FDA grants the Pri꽁 머니 바카라ity Review Designation to applications f꽁 머니 바카라 drugs that, if approved, would provide significant improvements in the safety and effectiveness of the treatment, diagnosis 꽁 머니 바카라 prevention of serious conditions.
The Pri꽁 머니 바카라ity Review Designation means that the FDA's goal is to take action on an NDA application within six months (compared to the ten months under standard review).
꽁 머니 바카라al C-DEC is an investigational compound and is not currently approved in any country.