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The number of new drugs approved each year has increased significantly since 1990. Various expedited approval pathways such as Orphan Drug Status designation, Accelerated Approval, Fast-Track, Priority Reviews, and the use of surrogate endpoints in studies have reduced the FDA review time from more than 3 years in 1983 to less than 1 year in 2017. In 2019, the FDA’s Center for Drug Evaluation and Research approved 48 novel drugs – a decline from 59 in 2018.
Novel drugs are often innovative products that serve previously unmet medical needs or significantly improve patient treatment. Twenty of the novel drugs approved in 2019 are first-in-class and others are significant therapeutic advances. This issue focuses on the new drugs or treatments that met these criteria in the therapeutic areas of acne, acute migraine, multiple sclerosis, plaque psoriasis, sleep disorders due to obstructive sleep apnea,and hypoactive sexual desire disorder in premenopausal women. Dosing and drug interactions are detailed in Table 1. Brief descriptions of selected, additional new drugs and combinations are shown in Table 2. Many biosimilars were FDA-approved in 2019; these are listed in Table 3. A brief explanation of biosimilars is also provided.
This program was developed by The Rx Consultant and published by Continuing Education Network, Inc. The Rx Consultant accepts no advertising or financial support from the pharmaceutical industry and is funded solely by the purchase of programs. The Rx Consultant is dedicated to providing unbiased, balanced information to health care practitioners.
Programs developed by The Rx Consultant are written by health care providers with expertise in the topic area, peer-reviewed, extensively edited, and fact-checked. This development process was created to insure that every program presents information that is current, accurate, relevant to "real world" health care providers, and written in an easy reading, "plain English" style.
The Rx Consultant is a publication of Continuing Education Network, Inc.
ACPE Universal Activity Number: 0428-0000-20-003-H01-P
Chief Editor and CE Administrator
Terry M. Baker, PharmD
Tracy Farnen, PharmD
James Chan, PharmD, PhD
Pharmacy Quality and Outcomes Coordinator
Associate Clinical Professor
Richard Ron Finley, B.S. Pharm.,R.Ph.
Consult Pharmacist Aging and Adult Health Services
Julio R. Lopez, PharmD, FCSHP
Adjunct Clinical Professor
Assistant Clinical Professor
Visiting Associate Professor and Lecturer
Pamela Mausner, MD
Helen Berlie, Pharm.D. CDE, BCACP
Ambulatory Care Specialist - Diabetes
Senior Editorial Advisor
Gerard Hatheway, PharmD, PhD
Belinda M. Danielson, RPh
Christopher M. DeSoto, PharmD
Angie S. Graham, PharmD
Cynthia Chan Huang, PharmD, MBA
Fred Plageman, PharmD
Editorial Advisor and Clinical Practice Consultant for Nurse Practitioners
Meuleman, RN, C, MS
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