1、Impact Innovation Predictability AccessCENTER FOR DRUG EVALUATION AND RESEARCH ADVANCING HEALTH THROUGH INNOVATIONNEW DRUG THERAPYAPPROVALS 2019January 2020www.fda.govAdvancing Health Through Innovation22019 New Drug Therapy ApprovalsTable of ContentsIntroduction.52019:Another Strong Year for Innova

2、tion and Advances.6CDERs Drug Therapy Approvals of 2019.10 Novel Drugs.10Impact of Novel Drug Approvals.12Drugs for Rare Diseases.13Innovation:Frequent Use of Expedited Development and Review Pathways.21Predictability:Meeting PDUFA Goals.23Access:First Cycle Approval and Approvals Compared to Other

3、Countries.24New and Expanded Uses of Already FDA-Approved Drugs.26New Uses.26New Populations.29Additional Approvals.32Biosimilars.32New Formulations and Other Notable Approvals.34New Dosage Forms and New Dosing Regimes.36Conclusion.3932019 New Drug Therapy Approvals4Advancing Health Through Innovati

4、on52019 New Drug Therapy ApprovalsIntroductionWelcome to the FDAs Center for Drug Evaluation and Researchs(CDER)annual report,Advancing Health Through Innovation:New Drug Therapy Approvals,reporting our Centers notable new drug approvals to the American public,and illustrating CDERs role in bringing

5、 innovative new drug therapies that are safe and effective to patients in need.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 advancing

6、patient care.Importantly,this report also goes beyond a discussion of novel approvals and includes an overview of an array of other notable approvals for instance,new approvals for uses of already FDA-approved drugs.Please take particular note of these other approvals.You will find,as in past years,