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 (.20 CEU)
Type of activity: Knowledge-based

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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.

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

Accreditation Statements

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

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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Target Audience

This accredited program is targeted to pharmacists and nurses.

Exam and 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.

Educational Goals and 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).