Recent FDA approvals (through May 2009) related to Coartem, Ixiaro, Lexapro, Reclast, and Symbyax
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Recent FDA action (through May 2009) related to budesonide/formoterol, sertindole, quetiapine, saxagliptin, bevacizumab, dronedarone, and ofatumumab
New indication: Tigecycline (Tygacil), a tetracycline-class antibiotic, was approved on March 20, 2009, for the treatment of community-acquired bacterial pneumonia
New molecular entity: Everolimus (Afinitor), an antineoplastic agent, was approved on March 30, 2009, for the treatment of advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib
Because so many people nowadays seem to be using cell phones rather than computers and e-mail to stay in touch, telemedicine programs are taking note of this trend and beginning to rely more on mobile phone technology.
Agents in late-stage development for the treatment of cystic fibrosis.
Labeling updates and warnings through April 2009 for insulin pens and cartridges
In a multinational prospective study published in the BMJ, investigators demonstrated that parenteral medication errors are common occurrences in intensive care units (ICUs), but the number of errors can be reduced through the use of error-reporting and electronic prescribing systems.
In a pilot study published in the Journal of the American Medical Association, investigators demonstrated that modafinil blocks dopamine transporters and increases dopamine levels in the brain, suggesting that this agent has the potential for abuse and addiction.
The headlines about contaminated heparin and tainted peanuts have put pressure on FDA to improve its methods for detecting unsafe medical and food products and to take swift action when problems emerge. The complaints are prompting the Obama administration to provide more resources for FDA while Congress weighs expanding agency operations and enforcement authority.
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This article reviews the similarities and differences between albuterol (ALB) and levalbuterol (LEV) to provide P&T committees a concise summary of the available literature regarding efficacy, side effects, and cost of these agents.
Generic drugs approved by FDA (through April 2009) including malathion lotion, 0.5%
Recent FDA action (through April 2009) related to alglucosidase alfa, bosentan, cetuximab, doxepin, telavancin, quetiapine extended-release, oxycodone/niacin, and EUR-1073
Recent FDA approvals (through April 2009) related to PegIntron, Rebetol, Apidra SoloSTAR, Temodar, Copaxone, and Edluar
Clevidipine is an intravenous (IV) dihydropyridine calcium-channel blocker (CCB) that is approved for the reduction of blood pressure (BP) when oral therapy is not feasible or not desirable. Clevidipine is effective at reducing BP in the emergency room (ER), intensive care unit (ICU), and in the pre-, peri-, and postoperative settings.
New indication: Budesonide/formoterol (Symbicort), a corticosteroid/LABA combination, was approved on February 27, 2009, for the maintenance treatment of COPD
Agents in late-stage development for the treatment of hospital-acquired pneumonia, Clostridium difficile-associated diarrhea, and complicated skin and skin-structure infections.
A retrospective cohort study published in the Journal of the American Medical Association demonstrated that concomitant use of clopidogrel and a proton-pump inhibitor (PPI) after hospital discharge for acute coronary syndrome (ACS) is associated with an increased risk of all-cause mortality and rehospitalization for ACS.
Apparently healthy people with normal cholesterol levels but elevated levels of high-sensitivity C-reactive protein (hsCRP) demonstrated a significant relative reduction in stroke risk if treated with rosuvastatin rather than placebo in the Justification for Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) study, according to data presented at the International Stroke Conference 2009.
Two-thirds of US hospitals do not administer tissue plasminogen activator (t-PA) to patients who have a stroke and are covered by Medicare, according to the results of a national study conducted between 2005 and 2007, which were presented at the International Stroke Conference 2009.
FDA has issued a public health advisory regarding a risk of burns during magnetic resonance imaging (MRI) scans in patients wearing transdermal medication patches that contain aluminum or other metals in the backing of the patches. The patches can overheat during the scan, leading to skin burns in the area of the patch.
FDA has stated that manufacturers of metoclopramide must add a boxed warning to their drug labels regarding the risk of tardive dyskinesia with long-term or high-dose use of this agent.
Synta Pharmaceuticals and GlaxoSmithKline have announced that they are suspending a phase 3 trial of elesclomol in chemotherapy-naïve patients with stage IV metastatic melanoma because of safety concerns.
At the 2009 annual meeting of the Generic Pharmaceutical Association (GPhA) in February, House Energy and Commerce Committee Chairman Henry Waxman told attendees that a workable scientific, regulatory, and legal pathway for follow-on biologics (also referred to as biogenerics or biosimilar pharmaceuticals) would lead to more affordable medications for Americans.
Catheter delivery of tissue plasminogen activator (t-PA) improves survival and functional outcomes at 6 months in patients with intraventricular hemorrhage (IVH), according to the final results from a phase 2b study known as Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR IVH).
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