New Drugs 2007-2008- Pharmacist

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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.

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Course Information

Target Audience

Pharm/Nurse Drug Therapy

Knowledge Level

General Overview

This activity will apply to a broad range of learning needs/pharmacy settings. It may include common disease state/therapy overivews and/or general pharmacy needs such as medication errors, immunizations, or law topics.

Learning Objectives

Course Accreditation

  • Activity Type:
    Knowledge
  • CE Broker
  • Universal Activity Number:
    Pharmacist : 428-0000-08-005-H01-P
PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

PharmCon, Inc. is an approved course provider for continuing education for nurses by the Florida Board of Nursing. PharmCon is also recognized by the California Board of Nursing as a provider of nursing programs.

In order to obtain a Statement of Credit, attendees must answer poll questions where presented and complete a program evaluation. Attendees may immediately print their Statement of Credit or leave them stored on the website.

Technology Requirements

  • Hardware Requirements
    Standard Windows/Mac System
    iPad or iPhone
    Minimum screen resolution: 1024x768
    Speakers or headphones
  • Software Requirements
    Standard Windows/Mac System
    iPad or iPhone
    Minimum screen resolution: 1024x768
    Speakers or headphones
  • Network Requirements
    Broadband Internet Connection:
    T1, Hi-speed DSL or Cable
    4G cellular connection
Computer sharing is NOT permitted due to accreditation guidelines on activity monitoring. Credit is earned by one user per device.