Hospital Pharmacy - April 2012 - (Page 305)

Hosp Pharm 2012;47(4):305–309 2012 Ó Thomas Land Publishers, Inc. www.thomasland.com doi: 10.1310/hpj4704-305 Current FDA-Related Drug Information Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals Danial E. Baker, PharmD, FASHP, FASCPp This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. Table 1. New drugs approved by the US Food and Drug Administration (FDA): January 16, 2012 through February 17, 2012 Axitinib – Inlyta (Pﬁzer) Comparative agents: Indication: Mechanism of action: Common adverse effects: None Treatment of advanced renal cell carcinoma after failure of one prior systemic therapy Kinase inhibitor Diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthesia (hand-foot) syndrome, decreased weight, vomiting, asthenia, and constipation Tablet; 1 mg and 5 mg http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202324lbl.pdf Nasal corticosteroids; beclomethasone, budesonide, ﬂunisolide, ﬂuticasone, mometasone, triamcinolone Symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older Corticosteroid Nasal discomfort, headache, and epistaxis Nasal aerosol; 37 mcg per actuation http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202129s000lbl.pdf Exenatide Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Glucagon-like peptide-1 (GLP-1) receptor agonist Nausea, diarrhea, headache, vomiting, constipation, injection site pruritus, injection site nodule, and dyspepsia Injection extended release; 2 mg http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022200s000lbl.pdf (continued) *Director, Drug Information Center, College of Pharmacy, Washington State University Spokane, PO Box 1495, Spokane, WA 99210-1495. Dosage form & strength: Product labeling: Comparative agents: Indication: Mechanism of action: Common adverse effects: Dosage form & strength: Product labeling: Exenatide - Bydureon (Amylin) Comparative agents: Indication: Mechanism of action: Common adverse effects: Dosage form & strength: Product labeling: Ciclesonide – Zetonna (Nycomed GmbH) Hospital Pharmacy 305 http://www.thomasland.com http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202324lbl.pdf http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202129s000lbl.pdf http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022200s000lbl.pdf

Table of Contents for the Digital Edition of Hospital Pharmacy - April 2012

Hospital Pharmacy - April 2012
Editorial
ISMP Medication Error Report Analysis
ISMP Adverse Drug Reactions
Cancer Chemotherapy Update
Off-Label Drug Uses
Original Article
Symptomatic Bradycardia, Syncope, and Prolonged Qtc Interval Associated With Dronedarone Therapy
Extended Stability of Magnesium Sulfate Infusions Prepared in Polyolefin Bags
Formulary Drug Reviews
Continuing Education Case Study Quiz (0.15 CEU)
Current FDA-Related Drug Information
Pharmacy Automation and Technology
Director’s Forum
Hospital Pharmacy Pulse
Index to Advertisers

Hospital Pharmacy - April 2012