美国FDA药物评价和研究中心（CDER）：2020年度新药获批报告（中译版）（44页）.pdf

1、ADVANCING HEALTH THROUGH INNOVATION:NEW DRUG THERAPY APPROVALS 2020 January 2021 www.fda.govIMPACT INNOVATION PREDICTABILITY ACCESSFDAs Center for Drug Evaluation and Research2Advancing Health Through Innovation 32020 New Drug Therapy ApprovalsTable of ContentsDirectors Message.42020:Another Strong

2、Year for Innovation and Advances .6CDERs Drug Therapy Approvals of 2020.10Novel Drugs .11CDERs Novel Drug Approvals of 2020.11CDERs Annual Novel Drug Approvals:2011-2020.12Innovation:Frequent Use of Expedited Development and Review Pathways.20Access:First Cycle Approval and Approvals Compared to Oth

3、er Countries.24New and Expanded Uses of Already FDA-Approved Drugs .26New Uses .26New Populations.32Additional Approvals .34Biosimilars.34New Formulations and Other Notable Approvals .35New Dosage Forms.36Conclusion.38Patrizia Cavazzoni,M.D.Acting Director,Center for Drug Evaluation and Research4Adv

4、ancing Health Through Innovation Directors MessageWelcome to the FDAs Center for Drug Evaluation and Researchs(CDERs)annual report,Advancing Health Through Innovation:New Drug Therapy Approvals,representing our tenth consecutive year of reporting our Centers notable new drug approvals,and our role i

5、n bringing innovative new drug therapies that are safe and effective to patients in need.Throughout the year,the COVID-19 pandemic presented unprecedented challenges to our entire staff.Despite these hardships,we have approved many new therapies that will advance health for the American public.This

6、includes the first FDA-approved drug for the treatment of patients with COVID-19.As with previous years,this years notable new drug therapies include a variety of novel drugs-those never before approved or marketed in the United States.Novel drugs often represent important new therapies for advancin