New Drugs 2007-2008
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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: 05/01/2008
Expiration Date: 05/31/2011
CE Credit: 2.0 (0.20 CEU)
Type of Activity: Knowledge-based
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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
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.
This accredited program is targeted to pharmacists and nurses.
Goals & Objectives
At the conclusion of this program, participants will be able to:
- For each of the new drugs reviewed:List the FDA approved indication(s).
- For each of the new drugs reviewed: Describe the mechanism of action, significant side effects and drug interactions. Provide 2-3 patient counseling tips.
- For each of the new drugs reviewed: Discuss the potential role in therapy.
- For each drug listed in Table 2: List the generic name, brand name and FDA approved indication(s).
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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
Editorial and Review Board
Chief Editor and CE Administrator
Terry M. Baker, PharmD
Tracy Farnen, PharmD
James Chan, PharmD, PhD
Pharmacy Quality and Outcomes Coordinator
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
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
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
Visiting Associate Professor and Lecturer
Samuel Merritt University
Pamela Mausner, MD
Helen Berlie, Pharm.D. CDE, BCACP
Clinical Assistant Professor, Pharmacy Practice
Wayne State University
Ambulatory Care Specialist - Diabetes
Health Centers Detroit Medical Group
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
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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