An investigation into a multistate outbreak of Serratia marcescens bloodstream infections (BSIs) published in the Archives of Internal Medicine found an association between the BSIs and contamination of prefilled syringes.
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New combination: Valturna was approved on September 16, 2009, for the treatment of hypertension in patients not adequately controlled on either aliskiren or angiotensin receptor blocker monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.
FDA is struggling to implement a host of new drug safety policies and programs and still meet review time frames set by the Prescription Drug User Fee program (PDUFA).
Bulletins that focus on drugs and therapeutic matters are often distributed by hospitals and other health systems that have programs for reporting adverse drug reactions.
In August 2003, the US Department of Veterans Affairs (VA) awarded a contract for prostaglandin ophthalmic agents with travoprost as the agent of choice. Although there was no national mandate to switch patients from existing therapy, many VA facilities had agreements from their local ophthalmology and optometry departments to conduct a therapeutic interchange of patients from existing prostaglandins (eg, latanoprost) to travoprost.
Recent FDA approvals (through November 2009) related to FluMist, Cervarix, Gardasil, Fluarix, Folotyn, Micardis, Twynsta, Votrient, Mirena
In a review published in The Cochrane Library, researchers determined that atovaquone-proguanil and doxycycline were well tolerated by most travelers and are less likely than mefloquine to cause adverse neuropsychiatric outcomes.
Cholesterol-lowering statin drugs do not reduce the risk of diabetes and might modestly elevate the chances of developing the condition, researchers found in a pooled analysis of trial data.
Atypical antipsychotic agents lead to a marked and rapid weight gain in children and adolescents, according to researchers at Zucker Hillside Hospital in Glen Oaks, NY and the Albert Einstein College of Medicine, NY.
Adding insulin to standard diabetes drugs results in better blood sugar control for many with type-2 diabetes, and the dose and timing of insulin received can make a big difference, British researchers report.
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Horizon Therapeutics Inc., a privately held biopharmaceutical company, recently presented an analysis from 2 pivotal phase 3 trials (REDUCE-1 and REDUCE-2) evaluating its lead investigational compound HZT-501, a combination of ibuprofen with high-dose famotidine, PRNewswire reports.
Three prescription diet drugs are in the final stages of development. According to USA Today, the drugs' manufacturers still have to submit their new drug applications to FDA and go through a rigorous review and approval process.
The federal government?s push to control health costs through comparative effectiveness research could threaten strides in personalized medicine, in which medicines are tailored to an individual?s genetic makeup, said the National Institutes of Health chief at a recent forum sponsored by the American Association for the Advancement of Science.
Specialty pharmacy's role in REMS, FDA's new drug safety program; Focus on Fampridine-SR; FDA leadership promotes scientific integrity, quality standards
Agents in late-stage development for the treatment of mixed dyslipidemia, coronary heart disease, atherosclerosis, and hypertension
Recent FDA approvals (through October 2009) related to Sabril, Helixate FS, Valcyte, Metozolv ODT, Xyzal, Zevalin, Extavia, Astepro, Zenpep, and Bepreve
FDA officials are taking steps to erase the charges of incompetency and ineffectiveness that have plagued the agency for several years.
New combination: Morphine/naltrexone extended-release capsules (Embeda) were approved on August 13, 2009, for the management of moderate-to-severe pain when continuous analgesia is needed for an extended time period
Recent FDA action (through October 2009) related to doxorubicin, trabectedin, carisbamate, alogliptin/pioglitazone, HPV vaccine, pralatrexate, romidepsin, hyaluronic acid, laromustine, clofarabine, prGCD, KNS-760704, rifaximin, hexvix, and quinazoline495
Generic drugs approved by FDA (through October 2009): 1% clindamycin/5% benzoyl peroxide gel, triamcinolone acetonide nasal spray, clonidine transdermal system, betamethasone acetate and betamathasone sodium phosphate injectable suspension
New formulation: Guanfacine extended-release tablets (Intuniv) were approved on September 2, 2009, for the treatment of attention-deficit/hyperactivity disorder (ADHD)
New molecular entity: Telavancin for injection (Vibativ) was approved on September 11, 2009, for the treatment of complicated skin and skin-structure infections (cSSSIs)
Fampridine-SR is a sustained-release oral medication that is pending FDA approval for the symptomatic treatment of multiple sclerosis (MS).
Specialty pharmacies are uniquely positioned to play a key role in the implementation of Risk Evaluation and Mitigation Strategies (REMS).
In an update to an earlier communication, FDA announced that the manufacturers of the leukotriene inhibitors montelukast (Singular), zafirlukast (Accolate), zileuton (Zyflo), and zileuton extended-release (Zyflo CR) are adding information about neuropsychiatric events to product labeling.
Novartis has issued a Dear Healthcare Professional letter regarding a risk of pure red cell aplasia (PRCA) in patients treated with mycophenolic acid (Myfortic).
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