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New Drugs 2007-2008

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Overview

   In 2007, the FDA approved 17 new molecular entities (NMEs) and 2 new biologic products - the lowest number since 1983. While the drug approval rate declined in 2007, the rate of "approvable letters" issued by the FDA increased substantially. An approvable letter is not considered a positive part of the process; it's issued when additional data are required before the FDA will move forward, which can significantly delay approval.

   The media has labeled the year a "drought" in terms of drug approvals. Industry analysts speculate that public criticism of the FDA over several high profile drugs including Vioxx®, Tysabri® and Avandia® may be a factor. The FDA may be taking a more cautious approach and asking for more information about drugs that carry risks, particularly if they lack clear advantages over older treatments. In addition, the number of applications for novel drugs from manufacturers has declined in recent years.

   Despite the decrease in numbers, 9 of the NMEs and the 2 biologic products approved in 2007 received "priority review status," the designation given to drugs that are considered major advances in treatment. Highlights for the year include the approval of the first new types of oral HIV drugs in many years, and new treatments for breast cancer, kidney cancer and leukemia.

   This issue will review the NMEs approved in 2007 that you are most likely to see in practice. For each drug, the indication, usual doses, and major drug interactions are listed in Table 1. A brief overview of additional NMEs, combination products, and formulations is provided in Tables 2, 3, and 4, respectively.

Publication Date: May-1-08
Expiration Date: May-31-11
CE Credit: 2.0 (0.20 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

Angie S. Graham, PharmD, Drug Information Coordinator, Stanford Hospital & Clinics and Assistant Clinical Professor of Pharmacy, University of California, San Francisco; James Chan, PharmD, PhD, Pharmacy Quality and Outcomes Coordinator, Kaiser Permanente, Oakland, CA and Assistant Clinical Professor, School of Pharmacy, University of California, San Francisco

Disclosure Statement

The Rx Consultant is a monthly publication dedicated to providing healthcare professionals with the information they need to educate patients about drugs. Any opinions expressed are those of The Rx Consultant staff. 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.

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 new drugs reviewed:List the FDA approved indication(s).
    2. For each of the new drugs reviewed: Describe the mechanism of action, significant side effects and drug interactions. Provide 2-3 patient counseling tips.
    3. For each of the new drugs reviewed: Discuss the potential role in therapy.
    4. For each drug listed in Table 2: List the generic name, brand name and FDA approved indication(s).

Exam & Credit Statement procedures

Upon successful completion of this program and the post test (70%), 2.0 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

Editor and CE Administrator

Terry M. Baker, PharmD

Associate Editor and CE Coordinator

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

Ron Finley, RPh
Lecturer
Department of Clinical Pharmacy
University of California San Francisco
San Francisco, CA

Associate Member of the UCSF Memory and Aging Center
Alzheimer's Research Center

Consultant Pharmacist to the Institute on Aging-On Lok Senior Health
Institute on Aging Alzheimer's Day Care Center

Angie S. Graham, PharmD
Drug Information Coordinator
Stanford Hospital and Clinics
Stanford University Medical Center
Stanford, 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

Joshua J. Neumiller, PharmD, CDE, CGP, FASCP
Assistant Professor
Department of Pharmacotherapy
College of Pharmacy
Washington State University
And
Elder Services of Spokane
Spokane, WA

Candy Tsourounis, PharmD
Professor of Clinical Pharmacy
Medication Outcomes Center
Department of Clinical Pharmacy
School of Pharmacy
University of California, San Francisco
San Francisco, CA

Senior Editorial Advisor

Gerard Hatheway, PharmD, PhD

Editorial Advisors

Jocelyn Chan, PharmD
Belinda M. Danielson, RPh
Christopher M. DeSoto, PharmD
Cynthia Chan Huang, PharmD, MBA
Fred Plageman, PharmD


Editorial Advisor and Clinical Practice Consultant for Nurse Practitioners

Emily K. Meuleman, RN, C, MS

CE for this article is no longer valid.

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.
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.

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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CE for this article is no longer valid.