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eChapter 71 (Part 2): The Goodman & Gilman Year in Review: 2011 New and Noteworthy FDA Approvals

Nelda Murri

PART 2 ADDITIONAL NOTEWORTHY AGENTS

The FDA approved 33 drugs and biologics of note in 2011. Most are pharmacologically similar to others already marketed (see Table 71-2). Among the remainder are 18 "first-in-class" agents for acute coronary syndrome, angioedema, chronic obstructive pulmonary disease, congenital factor XIII deficiency, depression, head lice, hepatitis C infection, lupus, lymphoma, melanoma, myelofibrosis, prostate cancer, seizures, diagnosis of Parkinsonian syndromes, and vaccination of military personnel against adenovirus (see part 1 of this series). Fourteen of the new drug approvals in 2011 were granted orphan drug status for rare diseases (see Table 71-2, Table 71-3, and part 1 of this series). Two of the new drugs (crizotinib for non-small cell lung cancer and vemurafenib for melanoma) were approved in conjunction with diagnostic genetic tests and represent a breakthrough in the field of personalized medicine.1 In addition, one new approval, HEMACORD is the first cord blood therapy approved in the US.2

Table 71-2.New Drugs Licensed in 2011 with Pharmacological Mechanisms Similar to Previously Approved Drugs
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Table 71-2. New Drugs Licensed in 2011 with Pharmacological Mechanisms Similar to Previously Approved Drugs
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Generic Name Brand Name Pharmacology 2010 FDA Approved Indication Pharmacologically Similar Agents Goodman & Gilman's The Pharmacological Basis of Therapeutics, 12e Reference
Aflibercept eylea vascular endothelial growth factor (VEGF-A and PlGF) antagonist wet (neovascular) age-related macular degeneration pegaptanib, ranibizumab Chapter 64. Ocular Pharmacology
azilsartan edarbi Angiotensin II Receptor Antagonist hypertension candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan Chapter 26. Renin and Angiotensin
belatacept* nulojix T-cell costimulation blocker prophylaxis against kidney transplant organ rejection abatacept Chapter 35. Immunosuppressants, Tolerogens, and Immunostimulants
centruroides (scorpion) immune F(abâ ™)2* anascorp antitoxin scorpion sting crotalidae polyvalent immune fab, digoxin immune Fab Chapter 4. Drug Toxicity and Poisoning
clobazam* onfi benzodiazepine adjunctive treatment of seizures associated with Lennox-Gastaut syndrome alprazolam, chlordiazepoxide, clonazepam, clonazepate, diazepam, lorazepam, oxazepam Chapter 17. Hypnotics and Sedatives
crizotinib* (approved with a companion diagnostic test for the ALK gene) xalkori tyrosine kinase inhibitor anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer dasatinib, erlotinib, gefitinib, imatinib, lapatinib, nilotinib, pazopanib, sunitinib Chapter 62. Targeted Therapies: Tyrosine Kinase Inhibitors, Monoclonal Antibodies, and Cytokines
deferiprone* ferriprox iron chelator iron overload due to thalassemia syndromes deferasirox, deferoxamine Chapter 67. Environmental Toxicology: Carcinogens and Heavy Metals
Fidaxomicin dificid macrolide antibiotic Clostridium difficile-associated diarrhea azithromycin, clarithromycin, erythromycin Chapter 55. Protein Synthesis Inhibitors and Miscellaneous Antibacterial Agents
Gadobutrol gadavist gadolinium-based contrast agent evaluation of blood brain barrier disruptions or other brain circulation abnormalities during MRI gadobenate dimeglumine, gadodiamide, gadopentetate dimeglumine, gadoteridol, gadoversetamide, gadoxetate (see Magnetic Resonance Imaging in Harrison's Principles of Internal Medicine, 18e)
hydroxyprogesterone caproate*≠makena progestin to reduce the risk of preterm birth medroxyprogesterone, megestrol, norethindrone, progesterone Chapter 40. Estrogens and Progestins
Indacaterol arcapta neohaler long-acting beta2-adrenergic agonist chronic obstructive pulmonary disease arformoterol, formoterol, salmeterol Chapter 36. Pulmonary Pharmacology

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