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eChapter 68: The Goodman & Gilman Year in Review: 2014 New and Noteworthy FDA Approvals

Nelda Murri, PharmD, MBA, Chief of Pharmacy, Jonathan M. Wainwright Memorial VA Medical Center, Clinical Assistant Professor, University of Washington School of Pharmacy

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    AMA Citation
    Murri, PharmD, MBA, Chief of Pharmacy, Jonathan M. Wainwright Memorial VA Medical Center, Clinical Assistant Professor, University of Washington School of Pharmacy N. Murri, PharmD, MBA, Chief of Pharmacy, Jonathan M. Wainwright Memorial VA Medical Center, Clinical Assistant Professor, University of Washington School of Pharmacy N Murri, PharmD, MBA, Chief of Pharmacy, Jonathan M. Wainwright Memorial VA Medical Center, Clinical Assistant Professor, University of Washington School of Pharmacy, Nelda.The Goodman & Gilman Year in Review: 2014 New and Noteworthy FDA Approvals. In: Brunton LL, Chabner BA, Knollmann BC. Brunton L.L., Chabner B.A., Knollmann B.C. Eds. Laurence L. Brunton, et al.eds. Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 12e New York, NY: McGraw-Hill; . http://accessbiomedicalscience.mhmedical.com/content.aspx?bookid=1613&sectionid=102165155. Accessed April 24, 2018.
    MLA Citation
    Murri, PharmD, MBA, Chief of Pharmacy, Jonathan M. Wainwright Memorial VA Medical Center, Clinical Assistant Professor, University of Washington School of Pharmacy N. Murri, PharmD, MBA, Chief of Pharmacy, Jonathan M. Wainwright Memorial VA Medical Center, Clinical Assistant Professor, University of Washington School of Pharmacy N Murri, PharmD, MBA, Chief of Pharmacy, Jonathan M. Wainwright Memorial VA Medical Center, Clinical Assistant Professor, University of Washington School of Pharmacy, Nelda.. "The Goodman & Gilman Year in Review: 2014 New and Noteworthy FDA Approvals." Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 12e Brunton LL, Chabner BA, Knollmann BC. Brunton L.L., Chabner B.A., Knollmann B.C. Eds. Laurence L. Brunton, et al. New York, NY: McGraw-Hill, , http://accessbiomedicalscience.mhmedical.com/content.aspx?bookid=1613&sectionid=102165155.

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PART 1: FIRST-IN-CLASS AGENTS

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The FDA approved 54 new drugs and biologics of note in 2014. Thirty-four new drugs are pharmacologically similar to others already marketed (see Part 2 of this chapter). The remaining 20 represent first-in-class agents indicated for the management of cancers, cardiovascular risk, hepatitis C virus (HCV) infection, insomnia, inflammatory bowel disease, leishmaniasis, lipodystrophy, mucopolysaccharidosis, onychomycosis, and pulmonary fibrosis, and for immunization against serogroup B meningococcal disease (eTable 68–1).

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eTable 68–1New Pharmacological Drug Classes Introduced in 2014
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eTable 68–1 New Pharmacological Drug Classes Introduced in 2014
PHARMACOLOGICAL CLASS FIRST TO BE ­MARKETED IN THE U.S. FDA-APPROVED INDICATION GOODMAN & GILMAN’S THE PHARMACOLOGICAL BASIS OF THERAPEUTICS, 12TH ED. REFERENCE
Aminoacyl-transfer ribonucleic acid (tRNA) synthetase (AARS) inhibitor Tavaborole (kerydin) Onychomycosis of the toenails

Chapter 57. Antifungal Agents

Chapter 65. Dermatological Pharmacology > Onychomycosis
Anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor Ceritinib$† (zykadia) Non–small cell lung cancer (NSCLC) Chapter 36. Pulmonary Pharmacology
Anti–programmed death receptor 1 (PD-1) blocker Nivolumab$† (opdivo) Melanoma

Chapter 60. General Principles of Cancer Chemotherapy

Chapter 62. Targeted Therapies: Tyrosine Kinase Inhibitors, Monoclonal Antibodies, and Cytokines; see also

Update: Programmed Cell Death-1 (PD-1) Pathway Checkpoint Inhibition: Immuno-oncology for Advanced Melanoma
Pembrolizumab$† (keytruda)
Bispecific (CD3/CD19) T cell–engaging (BiTE) monoclonal antibody Blinatumomab$† (blincyto) Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-ALL)

Chapter 35. Immunosuppressants, Tolerogens, and Immunostimulants > Antigens

Chapter 60. General Principles of Cancer Chemotherapy

Chapter 62. Targeted Therapies: Tyrosine Kinase Inhibitors, Monoclonal Antibodies, and Cytokines; see also eUpdate 62-2, Blinatumomab: A CD19-/CD3-Bispecific T-cell Engaging (BiTE) Antibody for B-cell Leukemia Immunotherapy—A First-in-Class Agent that Directs T Cells to Tumor Cell Targets18
α4β7 integrin antagonist Vedolizumab (entyvio) Ulcerative colitis; Crohn’s disease Chapter 47. Pharmacotherapy of Inflammatory Bowel Disease > Pathogenesis of Inflammatory Bowel Disease
Interleukin-6 (IL-6) inhibitor Siltuximab† (sylvant) Multicentric Castleman’s disease Chapter 62. Targeted Therapies: Tyrosine Kinase Inhibitors, Monoclonal Antibodies, and Cytokines > Mechanisms of Action
Leptin receptor (ObR) agonist Metreleptin† (myalept) Generalized lipodystrophy Chapter 1. Drug Invention and the Pharmaceutical Industry > Has the Target Been Validated?
Meningococcal group B vaccine Meningococcal group B vaccine$ (trumenba) Prevention of invasive meningococcal disease caused by N. meningitidis serogroup B Chapter 35. Immunosuppressants, Tolerogens, and Immunostimulants > Vaccines
Multiple kinase inhibitor Nintedanib$† (ofev) Idiopathic pulmonary fibrosis Chapter 61. Cytotoxic Agents > Clinical Toxicities
Unknown Pirfenidone*$† (esbriet)
N-acetylgalactosamine-6-sulfatase, recombinant Elosulfase alfa† (vimizim) Mucopolysaccharidosis type IVA (Morquio A syndrome) (See Mucopolysaccharidoses in Harrison’s Principles of Internal Medicine, 18th ed.)
NS5A protein inhibitor (ledipasvir) in combination with a nucleotide analog NS5B polymerase inhibitor (sofosbuvir) Ledipasvir in combination with sofosbuvir$ (harvoni) Hepatitis C virus genotype 1 infection Chapter 58....

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