www.fda.govJanuary 2019www.fda.govJanuary 2019ADVANCING HEALTH THROUGH INNOVATION2018 NEW DRUG THERAPY APPROVALSImpact | Innovation | Predictability | AccessCENTER FOR DRUG EVALUATION AND RESEARCH每日免费阅读行业报告1、每日星球内分享10+精品报告；2、不定时分享国际投行报告，脱水研报等；3、行业报告均为公开内容，版权归原作者所有，星球仅分享内部学习。扫描右侧二维码即刻加入【行业报告（免费） 】星球（此页只为更多需要行业报告的朋友提供便利，希望不会影响您的阅读，谢谢理解！）2Advancing Health Through InnovationTable of ContentsIntroduction ............................................................................................................................32018: Another Strong Year for Innovation and 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 Uses ............................................................................................................... 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 FDA’s Center for Drug Evaluation and Research’s (CDER) annual report, Advancing Health Through Innovation: New Drug Therapy Approvals. This report helps illustrate CDER’s role in bringing innovative new drug therapies that are safe and effective to patients in need. Many of this year’s new drug therapies are novel drugs --- those never 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 treat 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 applications. This report also highlights the year’s biosimilar approvals. Biosimilars have great potential for both patients and the entire health care system. As patents and exclusivity protections for biologics expire in the United States, we can expect many more biosimilars to be submitted for approval. More products on the market means greater competition that can lead to increased access to therapies and lower costs to patients.The decisions we made on these approvals were generally completed by or before their goal dates as defined by Congressionally-approved agreements with industry (referred to as user fee programs). Most were approved in the United States before any other country in the world. Throughout all of our approval evaluations, safety remains our top priority. Our annual Drug Safety Priorities report provides a valuable overview of the many ways we work to ensure safety for all of our approvals.Keep in mind that this report focuses on CDER approvals. FDA’s Center for Biologics Evaluation and Research (CBER) also approves many important therapies to advance and protect the health of the American public. For more information, please visit CBER’s web page for 2018 Biological Approvals.We trust this report will continue to promote greater understanding of the many ways CDER works to support innovation and improve treatments for patients.Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research2018 New Drug Therapy Approvals4Advancing Health Through Innovation2018: Another Strong Year for Innovation and Advances In 2018, FDA’s Center for Drug Evaluation and Research’s (CDER’s) new drug therapy approvals helped a wide range of patients suffering from many different medical conditions...
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