Formulary back issues from June 2007:
Pipeline preview
Jun 01, 2007; ... Approvable designations * Sipuleucel-T (Provenge, Dendreon) for the treatment of asymptomatic, metastatic, androgen-independent (hormonerefractory) prostate cancer * Tramadol (CIP-Tramadol ER, Cipher) for the treatment of mode rate-to-moderate Iy severe pain * ...
First-time generic approvals
Jun 01, 2007; ... Zolpidem immediate-release tablets, 5 and 10 mg (equiv to Ambien immediate-release tablets) MYLAN, TEVA, ROXANE, WATSON, RANBAXV, ...
New indication
Jun 01, 2007; ... Singulair Montelukast MERCK Leukotriene receptor antagonist approved for prevention of exercise-induced bronchoconstriction This agent is a selective, orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene (CysL)T, receptor, thus ...
New molecular entity
Jun 01, 2007; ... Altabax Retapamulin ointment. 1% GLAXOSMITHKLINE Antibacterial agent approved for the topical treatment of Impetigo caused by Staphylococcus aureus or Streptococcus pyogenes This semisynthetic pleuromutilin antibiotic selectively inhibits bacterial protein ...
Safety labeling updates & new warnings
Jun 01, 2007; ... FDA has requested that manufacturers of all antidepressant medications update the existing boxed warning on product labels to include warnings regarding increased risks of suicidal thinking and behavior (suicidality) in young adults aged 18 to 24 years during initial treatment (usually during ...
Inhaled corticosteroids may provoke oropharyngeal adverse events
Jun 01, 2007; ... Inhaled corticosteroids (ICSs) are associated with a risk of oropharyngeal adverse events, according to a meta-analysis published in the journal Annals of Allergy,Asthma & Immunology. The study was designed to measure the risk of ICS-induced oral candidiasis, dysphonia, and ...
FDA actions in brief
Jun 01, 2007; ... Zoledronic acid (Rectast, Novartis) was approved for the treatment of patients with Paget's disease of the bone. Antihemophilic factor/von Willebrand factor complex (Humate-P, CSL Behring) was approved for the prevention of excessive bleeding in patients with von Willebrand disease who ...
Oral, but not transdermal, estrogen use associated with increased risk of venous thromboembolism
Jun 01, 2007; ... Oral estrogen use in postmenopausul women may elevate the risk of venous thromboembolism (VTE); however, the use of transdermal estrogen dues not appear to increase the risk of VTE, according to the results of the Estrogen and Thromboembolism Risk (ESTHER) study. Additionally, the data suggest ...
Use of acetaminophen, NSAIDs, and aspirin linked to increased risk of hypertension in men
Jun 01, 2007; ... Men who use acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), or aspirin are at an increased risk of developing hypertension compared with nonusers (P≤.05 for all comparisons), according to the results of a large, retrospective, easecontrolled study published in the Archives of ...
New formulations
Jun 01, 2007; ... AzaSite Azithromycin ophthalmic solution 1% INSPIRE Antibacterial agent approved for the treatment of bacterial conjunctivitis Axithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible ...
Research demonstrates better first-year results with combination therapy than with monotherapy in patients with early RA
Jun 01, 2007; ... Initial combination therapy for early rheumatoid arthritis (RA) provides earlier clinical improvement and less progression of joint damage at 2 years compared with initial monotherapy, according to a randomized, controlled trial published in Annals of Internal Medicine. The previously published ...
Prevention and treatment of chemotherapy-induced nausea and vomiting: A review
Jun 01, 2007; ... Abstract Nausea and vomiting (emesis) are among the most distressing side effects of chemotherapy and are associated with significant clinical consequences and decreased health-related quality of life. The likelihood, severity, and duration of nausea and vomiting depend largely on the ...
Long-term aspirin use associated with reduced incidence of colorectal cancer
Jun 01, 2007; ... High doses of aspirin (ASA) for a 10 years may help reduce the incidence of colonic adenoma and colorectal cancer, according to research published in Annals of Internal Medicine. However, such a regimen could also cause harm. In this systematic review, researchers analyzed numerous ...
PPI treatment beneficial to patients with ulcer bleeding, according to meta-analysis
Jun 01, 2007; ... When used to treat patients with ulcer bleeding, proton-pump inhibitors (PPIs) effectively reduce the risk of rebleeding and the need for surgical intervention and repeated endoscopic treatment, according to a meta-analysis published in the journal Mayo Clinic Proceedings. This study was ...
Statins associated with fewer hospitalizations for sepsis in patients with CKD undergoing dialysis
Jun 01, 2007; ... Statins can reduce the risk of hospiialization for sepsis in patients with chronic kidney disease (CKD) who are receiving dialysis, according to the results of a large cohort study published in the Journal of the American Medical Association (JAMA). Although the efficacy of statins to ...
Bifeprunox
Jun 01, 2007; ... A partial dopamine-receptor agonist for the treatment of schizophrenia Abstract Schizophrenia is a chronic psychiatric disorder that affects an estimated 1% of the population. This disorder may be treated with typical (first-generation) or atypical (second-generation) agents; a ...
Inhaled corticosteroids associated with decreased risk of lung cancer in patients with COPD
Jun 01, 2007; ... In a large, nested cohort study published in the American Journal of Respiratory and Critical Care Medicine, the use of inhaled corticosteroids (ICSs) at doses ≥ 1,200 mcg/d was associated with a 61% reduction in the risk of developing lung cancer in patients with chronic obstructive ...
Ibuprofen demonstrated to be superior pain relief for pediatric musculoskeletal injuries
Jun 01, 2007; ... A single dose of ibuprofen provides better pain relief than acetaminophen or codeine for children requiring emergency treatment for musculoskeletal trauma, according to the results of a randomized, controlled trial published in the journal Pediatrics. Although studies have compared the ...
Sequential and combination drug therapies for MS associated with fewer lesions, reduced relapse rates
Jun 01, 2007; ... FROM THE AMERICAN ACADEMY OF NEUROLOGY 59TH ANNUAL MEETING Novel strategies for the treatment of relapsing remitting multiple sclerosis (RRMS) incorporate multiple agents used sequentially or in combination to suppress the development of new brain lesions and reduce relapse ...
Pregabalin provides relief from fibromyalgia-related pain
Jun 01, 2007; ... Patients with pain related to fibromyalgia syndrome (FMS) can experience a ≥50% reduction in pain if they are treated with pregabalin, according to the results of a 14-week study in which 745 patients were randomixed to either pregabalin (300,450, or 600 mg twice daily) or placebo. The ...
ECLIPSE: Clevidipine offers promising perioperative blood pressure control in phase 3 trial
Jun 01, 2007; ... In a phase 3 trial, the investigational dihydropyridine calcium antagonist clevidipine demonstrated less pronounced perioperative blood pressure excursions compared with other intravenous antihypertensive agents in patients undergoing cardiac surgery. The results of the trial were ...
Oral thrombin receptor antagonist plus standard antiplatelet therapy does not increase risk of bleeding among patients undergoing PCI
Jun 01, 2007; ... An oral thrombin receptor antagonist demonstrated no increase in major or minor bleeding when added to standard antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI), according to the results of a phase 2 clinical trial. These results were presented at the ...
EVEREST: Tolvaptan improves symptoms, volume status in patients with acute decompensated HF but offers no long-term impact
Jun 01, 2007; ... The investigational vasopressin receptor antagonist tolvaptan had no long-term impact on clinical events in patients hospitalized with acute decompensated heart failure (ADHF), by but the agent did improve symptoms and volume status over the short term, according to the results of the Efficacy ...
ARISE: Succinobucol delivers mixed results in phase 3 trial of patients with ACS
Jun 01, 2007; ... FROM THE 56TH ANNUAL SCIENTIFIC SESSION OF THE AMERICAN COLLEGE OF CARDIOLOGY Succinobucol, an investigational monosuccinic acid ester of probucol, was not associated with a reduction in a composite end point of major cardiovascular events in patients diagnosed with acute coronary ...
Web-based tools to improve case management
Jun 01, 2007; ... Case management is defined as a collaborative process of assessment, planning, facilitation, and advocacy for options and services to meet an individual's health needs through communication and available resources to promote quality cost-effective outcomes. Case management is becoming ...
Lawmakers still debating PDUFA IV
Jun 01, 2007; ... There has been considerable congressional action with regard to FDA-related legislation. The Senate recently approved the FDA Revitalization Act, setting the stage for further deliberations in the House over drug safety and FDA user fees. The House Energy and Commerce Committee has been ...
More comparative effectiveness research could be beneficial when assessing new medical treatments
Jun 01, 2007; ... Insurers, payors, and health policy experts are clamoring for additional evidence that compares the safety, efficacy, and cost of medical products and procedures. Members of Congress and health advisory boards are proposing various strategies for expanding the scope of comparative effectiveness ...