FDA has approved rivaroxaban tablets (Xarelto, Janssen Pharmaceuticals), a novel, once-daily, oral anticoagulant for the prevention of deep vein thrombosis, which may lead to a pulmonary embolism in people undergoing knee- or hip-replacement surgery. Xarelto is the only new oral anticoagulant with FDA approval for this indication.
FDA has approved once-daily indacaterol inhalation powder (Arcapta Neohaler, Novartis) 75 µg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Arcapta is not indicated for acute deteriorations of COPD or to treat asthma.
In the face of dozens of pink-clad demonstrators at the gates of FDA and many heartfelt pleas from women with metastatic breast cancer, an advisory committee to the agency voted unanimously at the end of June to hold firm in its recommendation that approval for Avastin (bevacizumab, Genentech/Roche) for breast cancer be withdrawn.
FDA approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people aged 18 and older.
In an effort to address the efficacy of various treatment options available to reduce pain and improve physical function and quality of life (QOL) in patients with painful diabetic neuropathy (PDN), a broad literature review was conducted and new guidelines were published online May 17 in Neurology, as well as presented at the American Academy of Neurology Annual Meeting in Honolulu.
FDA has announced more conservative dosing recommendations for erythropoiesis-stimulating agents (ESAs) when they are used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis, and death.
Intensive-dose statin therapy appears to be associated with an increased risk of new-onset diabetes compared with moderate-dose therapy, according to a meta-analysis of data from 5 statin trials published in the June 22/29 issue of JAMA.
The 5-alpha-reductase inhibitor dutasteride is associated with markedly lower BPH-related complication rates than the alpha-blocker tamsulosin, according to analysis of 2 large trials.
Individualized guidelines present a much more efficient way of using drugs and other treatments compared with current guidelines.
The incidence of Alzheimer's disease is expected to increase through the year 2050 with an estimated prevalence of 11 to 16 million cases. Two classes of medications are FDA approved for managing symptoms of AD, cholinesterase inhibitors and an N-methyl-D-aspartase receptor antagonist..
Generic drug approved by FDA (through June 2011): levofloxacin
Recent FDA Approvals (through June 2011) related to Oxecta, Creon, Lupron Depot, Nulojix, Zutripro Oral Solution, Potiga, Solesta, Dificid, Istodax, Rectiv, IaViv
FDA is developing guidelines for documenting similarity and interchangeability of copycat versions of biotech therapies, a process that is drawing considerable scrutiny from a broad spectrum of stakeholders.
With more and more costly drugs breaking the bank for patients and payers, managed care organizations are developing programs to reduce a small niche of waste associated with early discontinuation of medication therapy.
Comparative effectiveness research reviews are valuable resources for guiding medication use decisions, but they are underutilized, according to a recent presentation.
In a recently published study, researchers have presented new evidence suggesting that oral contraceptives containing drospirenone result in a greater than 2-fold increased odds of developing non-fatal, idiopathic venous thromboembolism compared to current users of products containing levonorgestrel.
The selective beta3-adrenoceptor agonist mirabegron effectively improves symptoms of overactive bladder and is very safe and well tolderated, according to results of a phase 3 study.
New studies confirm the lower levels of vitamin D are associated with a higher risk of developing diabetes and diabetic retinopathy.
New indication: Menactra Quadrivalent meningococcal polysacchardie diptheria toxoid conjugate vaccine was approved by FDA as treatment to prevent meningococcal disease in infants and toddlers as young as 9 months of age.
According to a new safety communication recently released by FDA, the agency is continuing to receive reports of a rare but aggressive white blood cell cancer often referred to as hepatosplenic T-cell lymphoma in patients receiving tumor necrosis factor blockers, azathioprine, and mercaptopurine.
New molecular entity: Vandetanib is a oral kinase inhibitor approved by FDA to treat progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
Some of the most prescribed blockbuster medications will lose market exclusivity in the next couple of years, according to a recent presentation.
Rivaroxaban is an oral, direct factor Xa inhibitor under review by FDA for stroke prevention in patients with atrial fibrillation. Atrial fibrillation conveys a 5-fold increased risk for stroke.
Recent FDA action (through June 2011) related to oxycodone, aflibercept opthalmic solution, icatibant, eculizumab, asimadoline, anthrax vaccine, SBC-102 enzyme replacement therapy, ciprofloxacin, mitosol, MORAb-004 and MORAb-066, levofloxacin.
In a recently published observational registry study, researchers have demonstrated that the utilizatio of evidence-based therapies in patients experiencing ST-elevation myocardial infarction is on the rise.
Low-cost generic drug programs pioneered by Wal-Mart and other big-box retailers are a mixed blessing for patients with diabetes.
Cancer is a complex, costly condition. However, emerging trends in the system at large are opening up opportunities for managed care.
The Vermont legislature and governor recently approved initial steps for establishing a single-payer system for the state
False Claims Act changes included expanding the scope by eliminating the intent requirement, and expanding liability for retaining government overpayments.
Managed care organizations are developing programs to reduce a small niche of waste associated with early discontinuation of medication therapy.