求助美国FDA同一商品名的药品为什么有两个NDA号呢?NDA 206088 This new drug application provides for the use of Otezla (apremilast) tablets, 10, 20 and 30 mg, for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 中度至重度斑块型银屑病 NDA 205437 This new drug application provides for the use of Otezla (apremilast) tablets , for the treatment of adult patients with active psoriatic arthritis (PsA). 银屑病关节炎（PsA） https://www.accessdata.fda.gov/d ... 437Orig1s000ltr.pdf 两个是不同的适应症。好比礼来的Taltz（Ixekizumab），2016年3月22日批准的适应症就是 the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 它现致力开发的第二个适应症是 active psoriatic arthritis (PsA)，具体进度未考究。这种情况，应该是可以多个NDA，也可以在原NDA基础上补充申请。（诺华的Cosentyx就是在原NDA基础上增至3个适应症，包括PsA、As、斑块型）查看更多
第1天
关注盖德视界
添加小助手
