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New Drugs 2014-2015, Part 1

New Drugs 2014-2015, Part 1

New Drugs 2014-2015, Part 1

James Chan, Pharm.D., PhD
James Chan, Pharm.D., PhD
on behalf of University of Texas at Austin College of Pharmacy

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Launch date: 09 Mar 2017
Expiry Date:

Last updated: 13 Mar 2017

Reference: 171026

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Description

2014 was an exciting year for new drug approvals and,according to Forbes, the best since the all-time record in 1996.The FDA approved 44 novel agents: 39 (excluding imaging agents) by the Center for Drug Evaluation and Research (CDER) and 5 (including only recombinant agents) by the Center for Biologics Evaluation and Research (CBER).Seventeen of the CDER approvals are considered first-in-class,and span 10 therapeutic areas led by infectious diseases, cancer, and rare diseases.Three more novel drugs were approved in the first 6 weeks of 2015;2 of the 3 are first-in-class. The increased rate of approvals may be related to the FDA’s effort to ensure that treatments for serious conditions are approved as soon as there is enough evidence that their benefits outweigh their risks. Four expedited programs were established: fast track designation, accelerated approval,priority review, and breakthrough therapy designation.Many of the recently approved drugs took advantage of these approaches. Given the large number of approvals, The Rx Consultant will publish 2 New Drugs issues this year. The first issue provides detailed reviews of inhaled human insulin,2 weight loss products, 2 products for chronic hepatitis C virus infection, and a first-in-class orexin receptor antagonist for insomnia. Usual doses and selected drug interactions are summarized in Table 1.Eleven more new drugs that are likely to be encountered in everyday practice are described in Table 2. Format This CE activity is a monograph (PDF file).

Objectives

Objectives
For each of the drugs reviewed, list the FDA approved indication(s), discuss the evidence supporting the approval, and discuss the potential role(s) in therapy. Describe the significant side effects and drug interactions of each of the drugs reviewed. Provide 2-3 patient counseling tips. For each drug listed in Table 2, List the generic name, brand name if applicable, and FDA approved indication(s).
James Chan, Pharm.D., PhD

Author Information Play Video Bio

James Chan, Pharm.D., PhD
on behalf of University of Texas at Austin College of Pharmacy

James Chan, PharmD, PhD, Pharmacy Quality and Outcomes Coordinator, Kaiser Permanente, Oakland, CA and Associate Clinical Professor, School of Pharmacy, University of California, San Francisco, CA.

Current Accreditations

This course has been certified by or provided by the following Certified Organization/s:

  • Accreditation Council for Pharmacy Education (ACPE)
  • 1.50 Hours -
    Exam Pass Rate: 75
    -
    Reference: 0428-000-15-003-H01-P

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