New Drugs 2009-2010
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The year 2009 held big changes for the Food and Drug Administration (FDA). Proposals sent to Congress called for expanding the agency's budget to $3.2 billion. If enacted, this would be the largest annual budget increase in the FDA’s history. Margaret Hamburg, MD, was confirmed as the new FDA commissioner. Although it is too soon to tell, some experts believe that her new leadership team is likely to focus more on drug safety than on rapid new drug approvals. Recent legislation has expanded the agency's authority to require, rather than simply request, post-marketing safety studies from drug manufacturers.
At the time of writing, a variety of new molecular entities had arrived on the market in 2009, but most were extensions of existing drug classes or “me-too” drugs. This article will focus on selected new drugs approved in 2009 that are likely to be of interest to the community-based practitioner including benzyl alcohol 5% (UlesfiaTM), dronedarone (Multaq®), febuxostat (Uloric®), pitavastatin (Livalo®), prasugrel (Effient®), saxagliptin (OnglyzaTM), tapentadol (NucyntaTM), iloperidone (FanaptTM), and asenapine (Saphris®). Each monograph summarizes the drug’s role in therapy, usual dose, precautions and drug interactions. Useful and practical patient counseling points are highlighted separately for easy access. Brief overviews for 8 additional new drugs are provided in a table. Other tables outline new formulations and new combination products you are likely to encounter in practice.
Publication Date: 03/01/2010
Expiration Date: 03/01/2013
CE Credit: 2.0 (0.20 CEU)
Type of Activity: Knowledge-based
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Angie S. Graham, PharmD, FCSHP, Medical Communications Scientist, Genentech, Inc., South San Francisco, CA and 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, CA.
Dr. Graham is an employee of Genentech, Inc., a wholly owned member of the Roche group. Valcyte®
(valgancyclovir), included in Table 3, is a Roche product. Dr. Chan reports no financial or personal relationships with any commercial interest
producing, marketing, reselling or distributing a product or service that appears in this issue.
This accredited program is targeted to
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 if applicable, and FDA approved indication(s).
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ACPE Universal Activity Number: 428-0000-10-003-H01-P
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
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
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