美国FDA药物评价和研究中心（CDER）：2018年度新药获批报告（英文版）（36页）.pdf

1、www.fda.govJanuary 2019www.fda.govJanuary 2019ADVANCING HEALTH THROUGH INNOVATION2018 NEW DRUG THERAPY APPROVALSImpact|Innovation|Predictability|AccessCENTER FOR DRUG EVALUATION AND RESEARCH2Advancing Health Through InnovationTable of ContentsIntroduction.32018:Another Strong Year for Innovation and

2、 Advances .4Novel Drugs .7Impact of Novel Drug Approvals .9Innovation:Frequent Use of Expedited Development and Review Pathways.18Predictability:Meeting PDUFA Goals.20Access:First Cycle Approval and Approvals Compared to Other Countries.21New and Expanded Uses of Already FDA-Approved Drugs .22New Us

3、es.22New Populations.25Additional Approvals .26Biosimilars.26New Formulations and Other Notable Approvals.28New Dosage Forms.30Conclusion.31Appendix A:Drug Designation Summary.32Appendix B:Novel Drug Designation Summary.342018 New Drug Therapy Approvals3IntroductionWelcome to the FDAs Center for Dru

4、g Evaluation and Researchs(CDER)annual report,Advancing Health Through Innovation:New Drug Therapy Approvals.This report helps illustrate CDERs role in bringing innovative new drug therapies that are safe and effective to patients in need.Many of this years new drug therapies are novel drugs-those n

5、ever before approved or marketed in the United States.Novel drugs often represent important new therapies for advancing patient care.Our report also highlights medically significant approvals for existing drugs.As in past years,many important advances in 2018 use an already FDA-approved drug to trea

6、t a new disease or a new population of patients,such as children.Our report emphasizes some of the many innovative ways we were able to evaluate safety and efficacy for these new therapies,as well as key regulatory tools we used to enhance our efficiency and expedite the review and approval of appli