1、Impact Innovation Predictability AccessCENTER FOR DRUG EVALUATION AND RESEARCHADVANCING HEALTH THROUGH INNOVATION:NEW DRUG THERAPYAPPROVALS 2021January 2022www.fda.govAdvancing Health Through Innovation2New Drug Therapy Approvals 2021Table of ContentsDirectors Message.5Executive Summary.6CDERs Novel

2、 Drug Approvals of 2021.10 First-in-Class Drugs.11Drugs for Rare Diseases.13Other Novel Drug Approvals.15Innovation:Use of Expedited Development and Review Pathways.16Fast Track.16Breakthrough Therapy.17Priority Review.17Accelerated Approval.18Overall Use of Expedited Development and Review Methods.

3、18Predictability:Meeting PDUFA Goals.19Access:First Cycle Approvals and First in U.S.Approvals.20New Uses of Approved Drugs.23Approved Drugs Expanded for New Pediatric Populations.25Biosimilar and Interchangeable Biosimilar Approvals.28Other Non-Novel Approvals.30Conclusion.33Appendix A:CDERs Novel

4、Approvals of 2021(in alphabetical order).34Appendix B:Novel Drug Designation.363New Drug Therapy Approvals 20214Advancing Health Through Innovation5New Drug Therapy Approvals 2021Directors MessageWelcome to FDAs Center for Drug Evaluation and Researchs(CDER)annual report,Advancing Health Through Inn

5、ovation:New Drug Therapy Approvals 2021,representing our 11th consecutive year of reporting CDERs notable human drug approvals.This report illustrates our role in bringing innovative drug therapies that are safe and effective to patients in need.Throughout the year,the COVID-19 pandemic continued to

6、 present significant challenges to our entire staff.In spite of these hardships,we have approved many therapies that will advance health for the American public.As in the past,this years new drug therapies span many areas of medicine and disease areas.This is our fifth consecutive year of publishing