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美国FDA批准Horizon公司提交的Rayos新药申请(NDA)。Rayos是新型的程序释放剂型的低剂量泼尼松(prednisone),用于治疗包括类风湿关节炎(RA)在内的一系列疾病。此批准是基于桥接泼尼松的程序释放剂型和速释剂型的药代动力学的数据以及代号为CAPRA-1和CAPRA-2研究的数据。CA-
The U.S. FDA approved the Rayos® New Drug Application (NDA) submitted by Horizon. Rayos is a new, prednisone-type, low-dose prednisone for the treatment of a range of diseases, including rheumatoid arthritis (RA). This approval is based on data on the pharmacokinetics of program-release and immediate release formulations of prednisone-bridged bridges and on the CAPRA-1 and CAPRA-2 studies. CA-