Formulary Watch |
All News - Page 148
US healthcare system among least cost-effective in reducing mortality
August 26, 2011
The United States healthcare system is one of the least cost-effective in reducing mortality rates; while the United Kingdom is among the most cost-effective, according to a recent study published in the July issue of Journal of the Royal Society of Medicine Short Reports.
FDA-approved cyanide antidote launches
August 26, 2011
An antidote indicated for the treatment of acute cyanide poisoning judged to be life-threatening has launched.
Once-daily rivaroxaban appears to be as effective as dose-adjusted warfarin
August 26, 2011
Once-daily oral rivaroxaban (Xarelto, Bayer), a direct factor Xa inhibitor, appears to be as effective as dose-adjusted warfarin in preventing stroke or major embolism in patients with nonvalvular atrial fibrillation, according to a study published online August 10 in the New England Journal of Medicine.
Children's dose-dependent CA-MRSA risk increases with antibacterial use
August 26, 2011
Antibacterial drug use in children is associated with a dose-dependant increased risk of acquiring community-associated methicillin-resistant Staphylococcus aureus (Ca-MRSA), according to the results of a population-based, case-control study reported online August 1 in the Archives of Pediatrics & Adolescent Medicine.
FDA approves Adcetris to treat 2 types of lymphoma
August 25, 2011
FDA has approved brentuximab vedotin (Adcetris, Seattle Genetics) to treat 2 types of lymphoma.
FDA approves Zelboraf and companion diagnostic test for late-stage skin cancer
August 19, 2011
FDA has approved vemurafenib (Zelboraf, Genentech), the second melanoma drug this year to improve overall survival. Zelboraf is indicated for the treatment of patients with late-stage (metastatic) or unresectable melanoma, the most dangerous type of skin cancer.
FDA approves 2 new strengths of leuprolide acetate for treatment of children with central precocious puberty
August 19, 2011
FDA has approved 2 new strengths (11.25 mg and 30 mg) for 3-month administration of leuprolide acetate for depot suspension (Lupron Depot-PED, Abbott) for the treatment of children with central precocious puberty.
FDA approves single-tablet regimen for HIV-1 infection in treatment-naïve adults
August 19, 2011
FDA has approved emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Complera, Gilead Sciences), a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults.
Results of biologics and specialty pharmacy research confirm knowledge gap
August 19, 2011
How much do employers know regarding biologics and specialty pharmacy?
FDA approves first antivenom for Centruroides scorpion stings
August 19, 2011
FDA has approved the first antivenom treatment specifically for a scorpion sting by the Centruroides scorpions in the United States. The new biologic treatment?called Anascorp?was designated an orphan drug and given priority review because adequate treatment did not exist in the United States, according to a consumer update and corresponding news release issued by the agency.
New guidelines for COPD diagnosis, management
August 19, 2011
The American College of Physicians (ACP), American College of Chest Physicians (ACCP), American Thoracic Society (ACT), and the European Respiratory Society (ERS) have issued updated recommendations to the 2007 ACP clinical practice guideline on diagnosis and management of stable chronic obstructive pulmonary disease (COPD). The new recommendations were published in Annals of Internal Medicine.
Statins may reduce risk of recurrent vascular events in young stroke patients
August 19, 2011
Young adults treated with a statin after a first ischemic stroke of undetermined cause were 77% less likely to suffer subsequent vascular events, according to a recent study published in Neurology.
FDA posts safety labeling changes for 32 products
August 19, 2011
Thirty-two products recently have had label changes to the boxed warnings, contraindications, and warnings sections, according to the FDA.
FDA warns unapproved emergency birth control may be ineffective, unsafe
August 19, 2011
FDA is warning consumers in the United States not to use an emergency birth control medicine labeled as Evital. According to a recent press release from the agency, Evital has not been approved by FDA, and the product may be a counterfeit version of the morning-after pill. It may not be safe or effective in preventing pregnancy.
Breaking news: CDC announces shortage of antimalarial drug primaquine
August 18, 2011
The Centers for Disease Control and Prevention warned this week that the antimalarial drug primaquine is not available until September, 2011.
Foundation for Managed Care Pharmacy appoints 4 new trustees
August 12, 2011
The Board of Trustees of the Foundation for Managed Care Pharmacy (FMCP), the educational and philanthropic arm of the Academy of Managed Care Pharmacy (AMCP), has announced the appointment of 4 new FMCP Trustees.
FDA, international counterparts report progress on drug inspection collaboration
August 12, 2011
The results of pilot programs focused on increasing international regulatory collaboration among the agencies that aim to enhance drug quality and safety globally, have been released by FDA together with its European and Australian counterparts.
American Regent recalls Vasopressin Injection, USP
August 12, 2011
American Regent, Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the retail/hospital level. The company initiated the product recall because some vials may not maintain potency throughout their shelf-life.
FDA warns fluconazole in early pregnancy may cause birth defects
August 12, 2011
FDA issued a warning this week that chronic high doses (400 mg/day to 800 mg/day) of fluconazole (Diflucan) during the first trimester of pregnancy may be associated with specific birth defects in infants. However, the risk does not appear to be associated with a single, low dose of fluconazole (150 mg), which is used to treat vaginal yeast infection (candidiasis), according to the Safety Alert released August 3.
Office of Generics Drugs reorganizes for greater efficiency
August 12, 2011
The Office of Generics Drugs (OGD) has been reorganized to improve coordination, communication, efficiency, and to enhance the Office?s ability to assure that all generic drugs are safe, effective, high quality, and interchangeable to the brand name drug product/reference listed drugs, according to The Center for Drug Evaluation and Research (CDER), part of FDA.
Transcept receives CRL from FDA for low-dose zolpidem tartrate formulation
August 5, 2011
FDA has issued a Complete Response Letter (CRL) for Intermezzo (zolpidem tartrate sublingual tablet, Transcept Pharmaceuticals).
First pharmacist-focused session coming to AHA Scientific Sessions 2011
August 5, 2011
Over the past 3 decades, pharmacists have become integrated members of multidisciplinary teams. To recognize the value of the role of pharmacists in improving patient outcomes and safety in cardiac care, the American Heart Association (AHA) will offer pharmacists a session focused specifically on them at this year?s AHA Scientific Sessions in Orlando, Fla.
PriCara, Ortho-McNeil now named Janssen Pharmaceuticals
August 5, 2011
PriCara and Ortho-McNeil, divisions of Ortho-McNeil-Janssen Pharmaceuticals, will operate under the name Janssen Pharmaceuticals, the family of companies announced this week. The change, effective immediately, is part of a global effort to unite the Janssen Pharmaceutical Companies around the world under a common identity and to increase collaboration, the statement said.
Novartis reports phase 3 results of Afinitor study
August 5, 2011
More than one-third of patients treated with everolimus (Afinitor) tablets had a 50% or greater reduction in the size of non-cancerous brain tumors associated with tuberous sclerosis complex (TSC) versus 0% who were treated with placebo, according to a company statement from the drug?s manufacturer Novartis.
IOM report recommends 8 preventive women's health services
August 5, 2011
A new report from the Institute of Medicine (IOM) recommends that 8 preventive health services for women will be added to the services that health plans will cover at no cost to patients under the Patient Protection and Affordable Care Act of 2010 (PPACA).
Poor glycemic control linked to potential risk for heart failure
August 5, 2011
Improving glycemic control may help prevent heart failure, according to a recent study published in The Lancet. The study enrolled at 20,985 patients with type 1 diabetes to assess variables associated with cardiovascular disease, including age, sex, duration of diabetes, HbA1c, body mass index, systolic and diastolic blood pressure, LDL and HDL cholesterol, and smoking status.
FDA approves subcutaneous formulation of abatacept for treatment of RA
August 5, 2011
FDA has approved a subcutaneous (SC)formulation of abatacept (Orencia, Bristol-Myers Squibb) for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA). It is the first biologic available in both SC and intravenous formulations for the treatment of RA.
FDA postpones new Prevnar ruling to January 2012
August 5, 2011
FDA has issued a 90-day extension of the action date for Pfizer?s Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in adults 50 years of age and older.
