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New Drugs 2014-2015 Part 1

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Overview

2014 was an exciting year for new drug approvals and,according to Forbes, the best since the all-time record in 1996.The FDA approved 44 novel agents: 39 (excluding imaging agents) by the Center for Drug Evaluation and Research (CDER) and 5 (including only recombinant agents) by the Center for Biologics Evaluation and Research (CBER).Seventeen of the CDER approvals are considered first-in-class,and span 10 therapeutic areas led by infectious diseases, cancer, and rare diseases.Three more novel drugs were approved in the first 6 weeks of 2015;2 of the 3 are first-in-class. The increased rate of approvals may be related to the FDA’s effort to ensure that treatments for serious conditions are approved as soon as there is enough evidence that their benefits outweigh their risks. Four expedited programs were established: fast track designation, accelerated approval,priority review, and breakthrough therapy designation.Many of the recently approved drugs took advantage of these approaches.

Given the large number of approvals, The Rx Consultant will publish 2 New Drugs issues this year. The first issue provides detailed reviews of inhaled human insulin,2 weight loss products, 2 products for chronic hepatitis C virus infection, and a first-in-class orexin receptor antagonist for insomnia. Usual doses and selected drug interactions are summarized in Table 1.Eleven more new drugs that are likely to be encountered in everyday practice are described in Table 2.

Details

Publication Date: 03/31/2015
Expiration Date: 03/30/2018
CE Credit: 1.5 (0.15 CEU)
Type of Activity: Knowledge-based

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.

Authors

James Chan, PharmD, PhD, Pamela Mausner, MD and Tracy Farnen, PharmD

Disclosure Statement

Dr. James Chan, Dr. Pamela Mausner, and Dr. Tracy Farnen report no financial or personal relationship with any commercial interest producing, marketing, reselling, or distributing a product or service that appears in this issue.

Target Audience

This accredited program is targeted to pharmacists and nurses.

Goals & Objectives

At the conclusion of this program, participants will be able to:

    1. For each of the drugs reviewed, list the FDA approved indication(s), discuss the evidence supporting the approval, and discuss the potential role(s) in therapy.
    2. Describe the significant side effects and drug interactions of each of the drugs reviewed. Provide 2-3 patient counseling tips.
    3. For each drug listed in Table 2, List the generic name, brand name if applicable, and FDA approved indication(s).

Accreditation Statements

The Rx Consultant is a publication of Continuing Education Network, Inc.

Continuing Education Network, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education as a provider of continuing pharmacy education.

Continuing Education Network is approved by the California Board of Registered Nursing, Provider Number CEP 13118. Programs approved by CA BRN are accepted by most State Boards of Nursing.

ACPE Universal Activity Number: 0428-0000-15-003-H01-P


Exam & Credit Statement Procedures

Upon successful completion of this program and the post test (70%), 1.5 hours of continuing education credit will be awarded. To receive credit and your exam score, please complete the exam questions and program evaluation.

Editorial and Review Board

Chief Editor and CE Administrator


Terry M. Baker, PharmD

Managing Editor


Tracy Farnen, PharmD

Associate Editors


James Chan, PharmD, PhD
Pharmacy Quality and Outcomes Coordinator
Kaiser Permanente
Oakland, CA

Associate Clinical Professor
School of Pharmacy
University of California San Francisco
San Francisco, CA

Richard Ron Finley, B.S. Pharm.,R.Ph.
Clinical Pharmacist (volunteer faculty)
University of California, San Francisco (UCSF) Memory and Aging Center
Lecturer (Emeritus) UCSF, Department of Clinical Pharmacy
Health Sciences Clinical Professor, UCSF School of Pharmacy
San Francisco, CA

Consultant Pharmacist
Ray Dolby Brain Health Center, Sutter Health/CPMC
San Francisco, CA

Consult Pharmacist Aging and Adult Health Services
San Francisco Health Department
San Francisco, CA

Julio R. Lopez, PharmD, FCSHP
Chief of Pharmacy Service
VA Northern California Health Care System

Adjunct Clinical Professor
College of Pharmacy
Touro University
Vallejo, CA

Assistant Clinical Professor
School of Pharmacy
University of California, San Francisco
San Francisco, CA Adjunct Professor
Thomas J. Long School of Pharmacy
University of the Pacific
Stockton, CA

Visiting Associate Professor and Lecturer
Nursing School
Samuel Merritt University
Oakland, CA

Pamela Mausner, MD

Helen Berlie, Pharm.D. CDE, BCACP
Clinical Assistant Professor, Pharmacy Practice
Wayne State University
Detroit, MI

Ambulatory Care Specialist - Diabetes
Health Centers Detroit Medical Group
Detroit, MI

Senior Editorial Advisor


Gerard Hatheway, PharmD, PhD

Editorial Advisors


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


Emily K.
Meuleman, RN, C, MS

About the Rx Consultant

The Rx Consultant is a monthly publication dedicated to providing health care professionals with the information they need to educate patients about drugs and manage drug therapy. The reader is responsible for confirming the information presented here and interpreting it in relation to each patient's specific situation before utilizing the information.

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