Oxybutynin extended-release tablets, 15 mg (equiv to Ditropan XL extended-release tablets, 15 mg)
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Imatinib (Gleevec, Novartis) was approved for relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia, certain forms of myelodysplastic/myeloproliferative diseases, aggressive systemic mastocytosis, hypereosinophilic syndrome and/or chronic eosinophilic leukemia, and unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans.
Telbivudine was approved on October 25, 2006, for the treatment of chronic hepatitis B virus (HBV) in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
The US Department of Justice (DOJ) and Medco Health Solutions, a large pharmacy benefit manager (PBM) based in Franklin Lakes, NJ, reached a settlement over allegations that the PBM had submitted false claims to the federal government, had paid kickbacks to health plans to obtain business, and had both solicited and accepted kickbacks from pharmaceutical companies.
The Oklahoma City Veterans Affairs Medical Center restructured its formulary system in 2003, creating a system of restrictive criteria for certain drugs to improve pharmaceutical cost effectiveness by enforcing evidence-based indications in the prescription system. The new criteria-restriction system required the use of formulary drugs as first-line therapy; prescriptions for nonpreferred, criteria-restricted drugs had to be justified by the prescriber at the time of prescription in accordance with the criteria established by the pharmacy and therapeutics (P&T) committee. To determine the effects of the system on cost avoidance and prescriber opinion, we analyzed drug utilization statistics and surveyed prescribers. Analysis demonstrated that the criteria-restriction system was an effective cost-avoidance tool because inappropriate prescriptions for restricted, high-cost drugs were curtailed in favor of lower-cost formulary alternatives. The total cost avoidance observed after placing 15 outpatient drugs in..
Methicillin-resistant Staphylococcus aureus (MRSA) strains showing reduced susceptibility to vancomycin (minimum inhibitory concentration [MIC] of 2 mcg/mL) and requiring aggressive empiric vancomycin dosing are highly prevalent among those that cause invasive infections, according to a prospective cohort study.
The American Heart Association (AHA) Scientific Sessions comprise the world's largest conference for scientists and healthcare professionals focusing on cardiovascular disease. The 2006 AHA Scientific Sessions, which took place Nov. 12–15 in Chicago, Ill, featured invited lectures and investigative reports. The conference included presentations on trials that evaluated investigational therapeutic agents, existing drugs and drug-related devices, and approved agents in alternative regimens or for alternative indications.
Cardiac function is regulated in part by the renin-angiotensin-aldosterone system, and current cardiovascular therapies work to antagonize this system by inhibiting the generation or action of angiotensin II. Aliskiren is the first drug to be reviewed by FDA in a new class of antihypertensive agents that directly inhibit the action of renin.
Women who take prescribed non-steroidal anti-inflammatory drugs (NSAIDs) in early pregnancy, specifically the first trimester, may increase their risk of giving birth to a child with congenital anomalies, especially cardiac septal anomalies, compared with women who do not take NSAIDs during this period, according to a recent study published in Birth Defects Research (Part B).
Adverse drug events (ADEs) led to the treatment of an estimated 701,547 patients in US emergency departments (EDs) in 2004 and 2005, according to a recent study in the Journal of the American Medical Association (JAMA). Significantly, those patients ?65 years of age were 2 times more likely to have ED treatment for an ADE and approximately 7 times more likely to need hospitalization than their younger counterparts.
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Approvable designations; Nonapprovable designation; Fast-track designations; Priority review; Orphan drug designations
Infliximab was approved on October 13, 2006, for the reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and elimination of corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
Pramipexole was approved on November 7, 2006, for the treatment of moderate-to-severe primary restless legs syndrome (RLS).
Telbivudine was approved on October 25, 2006, for the treatment of chronic hepatitis B virus (HBV) in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Review of agents in late-stage development for the treatment of ankylosing spondylitis, osteoarthritis, and related pain (December 2006).
Low levels of testosterone are associated with an increased risk of mortality from coronary heart disease (CHD) in postmenopausal women, reported Gail A. Laughlin, PhD.
Men who suffer from migraines are at increased risk for cardiovascular events, according to researchers. The new findings follow similar reports that women with migraines are at higher risk for cardiovascular disease.
A change in resting heart rate in healthy middle-aged men is tied to mortality risk, with those who experience a long-term rise in resting heart rate having an increased risk of mortality and those with a long-term decrease in resting heart rate having a reduced risk of mortality.
After years of minimal results, stem cell research is forging ahead. "This is a new appetizer for what may be an excellent meal in years to come," said former AHA president Valentin Fuster, MD, PhD, at a press briefing Tuesday morning. "Reports the past couple of years have been equivocal at best."
A rise in hemoglobin of at least 1 g/dL appears necessary to affect the course of heart failure in patients with symptomatic heart failure and anemia, according to a post hoc analysis of STAMINA-HeFT (Studies of Anemia in Heart Failure-Heart Failure Trial).
The practice of late reperfusion-percutaneous coronary intervention (PCI) performed 2 to 28 days after myocardial infarction (MI)-in patients who are stable does not lead to improved clinical outcomes compared with medical therapy, said Judith S. Hochman, MD, lead investigator of the Occluded Artery Trial (OAT).
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Pharmacist-directed education combined with prepackaging of medications increases compliance with medication schedules, leading to improvements in blood pressure and cholesterol levels among elderly patients, according to a study headed by Allen J. Taylor, MD.
The thiazolidinedione pioglitazone has a beneficial effect on carotid intima media thickness (CIMT) compared with glimepiride in patients with type 2 diabetes, said Theodore Mazzone, MD, lead investigator of the CHICAGO (Carotid Intima Media Thickness in Atherosclerosis Using Pioglitazone) study.
The first-ever anticoagulant drug-plus-antidote system has passed initial safety trials at Duke University in Durham, N.C. The new platform combines a short nucleic acid chain that quickly blocks clotting with an antidote that removes the clotting blockage in minutes.
Researchers in Japan have created the first heart valves using the recipients' own tissues-in rabbits. Growing replacement valves in a host with host tissue could virtually eliminate rejection when the valve is implanted.
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