New Drugs 2019 – Nurse Practitioner

  Price  $10.00

  Credits  2


The number of new drugs approved each year has increased significantly since 1990. Various expedited approval pathways such as Orphan Drug Status designation, Accelerated Approval, Fast-Track, Priority Reviews, and the use of surrogate endpoints in studies have reduced the FDA review time from more than 3 years in 1983 to less than 1 year in 2017. In 2019, the FDA’s Center for Drug Evaluation and Research approved 48 novel drugs – a decline from 59 in 2018. Novel drugs are often innovative products that serve previously unmet medical needs or significantly improve patient treatment. Twenty of the novel drugs approved in 2019 are first-in-class and others are significant therapeutic advances. This issue focuses on the new drugs or treatments that met these criteria in the therapeutic areas of acne, acute migraine, multiple sclerosis, plaque psoriasis, sleep disorders due to obstructive sleep apnea,and hypoactive sexual desire disorder in premenopausal women. Dosing and drug interactions are detailed in Table 1. Brief descriptions of selected, additional new drugs and combinations are shown in Table 2. Many biosimilars were FDA-approved in 2019; these are listed in Table 3. A brief explanation of biosimilars is also provided.


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Course Information

Target Audience

Nurse Practitioner

James Chan
PharmD, PhD
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

  • For each of the drugs reviewed:
  • 1. List the FDA approved indication(s), state the recommended dose(s), and discuss the evidence supporting the drug’s approval and potential role(s) in therapy.
  • Describe significant side effects and drug interactions.
  • Provide 2-3 patient counseling tips.
  • For drugs listed in Tables 2 and 3:
  • List the generic/brand names, dosage form(s), FDA approved indication(s), and major safety concerns if discussed. Describe a biosimilar product and how it differs from a generic product.
  • Course Accreditation

    • Activity Type:
    • CE Broker
    • Universal Activity Number:
      Nurse Practitioner : 0798-0000-21-196-H01
    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.