Formulary Watch |
All News - Page 160
Fentanyl sublingual tablets (Abstral): An opioid analgesic for the management of breakthrough pain in cancer patients
March 1, 2011
New formulation: Fentanyl sublingual tablets were approved by FDA to manage breakthrough pain in patients aged ?18 years who are already receiving and tolerant to opioids for their underlying persistent cancer pain.
First-time generic approvals March 2011
March 1, 2011
Generic drugs approved by FDA (through February 2011): Galantamine hydrobromide
Health system databases support comparative studies, quality assessment, and regulatory decision-making
March 1, 2011
The active drug safety surveillance system being established by FDA promises to do more than obtain timely adverse event information on marketed medicines.
Vilazodone hydrochloride (Viibryd): A selective serotonin reuptake inhibitor and partial 5HT1A receptor agonist for the treatment of major depressive disorder
March 1, 2011
New molecular entity: Vilazodone hydrochloride tablets were approved by FDA on January 21, 2011, for the treatment of major depressive disorder in adults.
FDA Actions in Brief March 2011 (Edarbi, Gralise, Rituxan, Menveo, Makena, Corifact, Epicyn HydroGel)
March 1, 2011
Recent FDA Approvals (through February 2011) related to Edarbi, Gralise, Rituxan, Menveo, Makena, Corifact, Epicyn HydroGel
Treatment of bipolar disorder: A focus on medication therapy for mania
March 1, 2011
In recent years there has been an explosion of new investigations into the pathophysiology of bipolar disorder and its medication therapies. This article will review current, emerging, and controversial therapies for the treatment of bipolar disorder, specifically the mania aspect.
Ceftaroline: A novel cephalosporin with methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcus pneumoniae activity
March 1, 2011
Ceftaroline has demonstrated activity against methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcus pneumoniae as well as common respiratory Gram-negatives including Haemophilus, Moraxella, and Klebsiella species.
FDA approves azilsartan medoxomil to treat hypertension
February 28, 2011
FDA approved azilsartan medoxomil tablets (Edarbi, Takeda Pharmaceutical North America) to treat hypertension in adults.
Drugs in short supply: Change and challenge among all stakeholders
February 25, 2011
Unprecedented levels of drug shortages, especially those drugs for which there are no substitutes, has prompted legislators to take action. Since the inception of the FDA Drug Shortage Program in 2000, the agency has been tracking the nation?s prescription pharmaceuticals and publishing a list of drugs in short supply.
Two drugs show promise in advanced pancreatic neuroendocrine tumors
February 24, 2011
Sunitinib and everolimus improved progression-free survival in patients with advanced pancreatic neuroendocrine tumors, according to 2 recent studies.
Black box warnings accelerate reduced antipsychotic use in dementia
February 24, 2011
The rate of decline in the use of atypical antipsychotics in outpatients with dementia accelerated following a black box warning by FDA, according to a multicenter study of national Veterans Affairs data.
TXA reduces death from bleeding in trauma patients
February 24, 2011
Tranexamic acid reduces the risk of death from bleeding without increasing the risk of vascular occlusive events or the need for surgical intervention in patients with acute traumatic injury, according to a review published in the 2011 Cochrane Database of Systematic Reviews.
FDA warns against terbutaline for preterm labor
February 24, 2011
FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor because of the risk for serious maternal heart problems and death.
Merck Serono pulls European application for oral MS drug Movectro
February 23, 2011
Merck Serono Europe informed the European Medicines Agency that it was withdrawing its marketing authorization application for oral cladribine (Movectro), 10-mg tablets, intended for the treatment of relapsing-remitting multiple sclerosis.
Forest to acquire Clinical Data
February 23, 2011
Forest Laboratories $1.2 billion acquisition of Clinical Data, the developer of Viibryd (vilazodone HCl) for the treatment of adults with major depressive disorder, is expected to allow Forest to leverage its existing presence in the antidepressant category.
FDA approves Corifact to prevent bleeding in people with rare genetic defect
February 18, 2011
FDA has approved Corifact (CSL Behring), the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.
FDA fast tracks Vascugel
February 18, 2011
FDA has granted fast-track designation to a novel endothelial cell-based therapy (Vascugel, Pervasis) for the prevention of hemodialysis access failure in patients with end-stage renal disease.
Herpes zoster vaccine on back order
February 18, 2011
Less than 1 month after the Centers for Disease Control and Prevention?s Advisory Committee on Immunization Practices recommended that most Americans aged 60 years and older get vaccinated to prevent herpes zoster, the vaccine (Zostavax, Merck) is on back order.
Rosiglitazone label and medication guide updated with cardiovascular risks
February 18, 2011
FDA has announced that the physician labeling and patient medication guide for rosiglitazone (Avandia, GlaxoSmithKline) have been changed to include information on cardiovascular risks (including death) of this agent.
ACIP revises adult immunization schedule for 2011
February 18, 2011
The Advisory Committee on Immunization Practices announces several changes to the recommended adult immunization schedule for 2011.
Variations in DMARD receipt exist in Medicare managed care patients with RA
February 18, 2011
An analysis of data from more than 90,000 Medicare managed care enrollees who received care for rheumatoid arthritis found that more than one-third did not receive the recommended treatment with a disease-modifying antirheumatic drug, and that receipt varied by demographic factors, socioeconomic status, geographic location, and health plan, according to a study in JAMA.
Oseltamivir oral suspension on back order due to increased demand
February 18, 2011
Oseltamivir phosphate oral suspension (Tamiflu) is on back order due to increased demand, manufacturer Genentech announced.
Sanofi-aventis to acquire Genzyme
February 17, 2011
The $20.1 billion acquisition of Genzyme by Sanofi-aventis will allow Sanotif-aventis to expand its footprint in biotechnology and give it an edge in the market for drugs for rare diseases, according to experts.
Zinc may shorten common cold
February 16, 2011
Zinc, in lozenge or syrup form, is beneficial in reducing the duration and severity of the common cold in healthy people, when taken within at least 24 hours of onset of symptoms, according to a new report published in the Cochran Library.
FDA issues CRL for Contrave
February 11, 2011
FDA has issued a complete response letter for Orexigen's and Takeda's Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.
FDA approves drug to prevent premature births
February 11, 2011
FDA has approved hydroxyprogesterone caproate injection (Makena [formerly known as Gestiva], Hologic and KV Pharmaceutical Co.), the first drug to help prevent premature delivery before 37 weeks in women who have had at least 1 previous preterm birth.
FDA approves vaccine for meningococcal disease in children
February 11, 2011
FDA has approved a vaccine for preventing meningococcal disease in children.
Vaccine may help patients avoid herpes zoster recurrence
February 11, 2011
Recurrences of herpes zoster may be more common in immunocompetent adults than once thought, according to a study published in the February issue of Mayo Clinic Proceedings, as reported in Newswise.
