New Drugs Approved in 2015- Pharmacist


  Credits  2

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In 2015, the FDA’s Center for Drug Evaluation and Research (CDER) approved 45 new molecular entities – the highest annual number of new drugs to be approved in the past decade (up from 41 in 2014). The new approvals include 16 first-in-class drugs spanning 14 different medical conditions. Many of the new drugs were approved under one or more of the FDA’s 4 expedited pathways (fast track, breakthrough, priority review, and accelerated approval). Nearly half are for the treatment of rare diseases that affect 200,000 or fewer Americans. A number of the new drugs treat various cancers, including multiple myeloma, lung cancer, melanoma, basal cell carcinoma, neuroblastoma, breast, colorectal, and thyroid cancers. The new approvals also include drugs for heart failure, high cholesterol, irritable bowel syndrome, hepatitis C, and cystic fibrosis, as well as a reversal agent for the oral anticoagulant dabigatran. This issue provides detailed reviews of 2 PCSK9 inhibitors for LDL cholesterol lowering; 2 products for irritable bowel syndrome with diarrhea; a drug for hypoactive sexual desire disorder in premenopausal women; a selective uric acid reabsorption inhibitor for patients with gout; and a novel treatment for severe eosinophilic asthma. Four new oral cancer drugs – 2 for nonsmall cell lung cancer and 2 for multiple myeloma – are also briefly reviewed. Usual doses and selected drug interactions are summarized in Table 1. Nine more new drugs that are likely to be relevant in everyday practice are described in Table 2. Both tables include pronunciation guides.


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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:
  • CE Broker
  • Universal Activity Number:
    Pharmacist : 0428-0000-16-004-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.