Agents in late-stage development for the treatment of mixed dyslipidemia, coronary heart disease, atherosclerosis, and hypertension
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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).
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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).
FDA is reviewing reports of liver injury in patients treated with orlistat (prescription drug, Xenical; OTC drug, Alli) for obesity management or weight loss.
Tibotec has issued a Dear Healthcare Professionals letter regarding an increased risk of fatality caused by toxic epidermal necrolysis and hypersensitivity reactions, sometimes accompanied by hepatic failure, in patients treated with etravirine (Intelence).
Pharmacists can improve patient outcomes by following 3 major functions: identification of potential and actual medication-related problems (MRPs), resolution of actual MRPs, and prevention of potential MRPs. The best way to achieve these goals is through accurate documentation, and one of the chief obstacles to this is time?or rather the lack of it. Various software programs have been developed to help pharmacists reduce time spent identifying opportunities for interventions.
In the Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography III (DECREASE III) trial published in the New England Journal of Medicine, patients undergoing noncardiac vascular surgery who were treated with perioperative fluvastatin demonstrated a lower incidence of myocardial ischemia than patients treated with placebo.
In the Study of Platelet Inhibition and Patient Outcomes (PLATO) published in the New England Journal of Medicine, patients with acute coronary syndrome (ACS) who were treated with ticagrelor had significant reductions in the rate of death from vascular causes, myocardial infarction (MI), or stroke and no significant increase in the rate of overall major bleeding versus patients treated with clopidogrel.
P&T considerations in fashioning a knowledge base, action plan for cardiometabolic disorders and weight; Focus on golimumab; Drug Watch: Agents in late-stage development for the treatment of gastrointestinal disorders
Even before the emergence of the swine flu pandemic, biopharmaceutical companies were investing in vaccines and treatments for lethal diseases that plague much of the world. There is growing recognition that Americans and Europeans are vulnerable to infections from overseas, and that development of new medications is critical to ensuring public health.
New indication: Bevacizumab (Avastin), a monoclonal antibody, was approved on July 31, 2009, for the treatment of metastatic renal cell carcinoma in combination with interferon alfa
Generic drug approved by FDA (through September 2009): tacrolimus capsules
The P&T committee is positioned to provide knowledge, strategies to improve treatment of patients with cardiometabolic disorders.
Recent FDA approvals (through September 2009) related to Saphris, Tracleer, Livalo, Tyvaso, Tekturna HCT, Onsolis, Forteo, Invega Sustenna, Colcrys, Acuvail, Lipsovir, and Kogenate FS
New molecular entity: Saxagliptin (Onglyza), a DPP-4 inhibitor, was approved on July 31, 2009, for the treatment of type 2 diabetes mellitus
New formulation: Sumatriptan (Sumavel DosePro) formulated as a needle-free injection was approved on July 15, 2009, for the acute treatment of migraine and cluster headaches
Recent FDA action (through September 2009) related to cethromycin, pegloticase, guanfacine, denosumab, apaziquone, TZP-102, and beclomethasone 17,21-dipropionate
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