Telaprevir (Vertex)In January, the U.S. FDA accepted for filing Vertex's New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review. A target review date of May 23, 2011 was set under the Prescription Drug User Fee Act (PDUFA) for the FDA's approval decision.
今年一月,美国FDA接受申请的telaprevir顶点的新药申请(NDA)及给予六个月的优先审核该公司的请求。一个5月23日审查2011年的目标日期定在处方药用户收费法(PDUFA)为美国FDA批准的决定。
Boceprevir, Merck's Investigational Oral Hepatitis C Protease Inhibitor, Receives FDA Priority Review and EMA Accelerated Assessment
Whitehouse Station, N.J., USA -- January 6, 2011 -- Merck, known as MSD outside the United States and Canada, announced today that regulatory applications for boceprevir, Merck's investigational oral hepatitis C virus (HCV) protease inhibitor, were submitted in 2010 and have been accepted for expedited review in both the U.S. and the European Union.
Boceprevir,默克的口服丙型肝炎蛋白酶抑制剂,获得FDA优先审查和评估均线加速