In a safety announcement, FDA notified the public that that an additional concentration of liquid acetaminophen marketed for "infants" (160 mg/5 mL) is now available at local stores.
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New drugs to treat chronic obstructive pulmonary disease (COPD) have increased treatment options. However, they have also caused health plans to re-evaluate their chronic-condition management strategies.
Paying for performance will cause many health plans to rethink how they contract with provider networks, and experts say there are tremendous changes ahead.
Recent FDA Approvals (through December 2011) related to (Antares, Isentress, REMS)
New indication: Tadalafil once-daily 5-mg oral tablet is FDA approved for the treatment of benign prostatic hyperplasia (BPH) in patients with or without erectile dysfunction (ED).
New indication: FDA approved rivaroxaban once-daily oral tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular AF.
Election-year politics will color a range of legislative and policy developments affecting drug development, production, and reimbursement in the coming year, as efforts to reduce government spending on healthcare prompts all parties to search for opportunities to do more with less. Looming over the political landscape is the upcoming Supreme Court decision on the constitutionality of the Obama health reform legislation.
New molecular entities (NMEs) for calendar year 2011 number 30, considerably above the average of 23 during the past 10 years. Notably among this list are 8 drugs for cancer; 10 targeting orphan diseases; 2 each for hepatitis C and chronic obstructive pulmonary disease (COPD); and 3 anticoagulants.
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The oral anticoagulant rivaroxaban lowered the risk of death, heart attack, and stroke in acute coronary syndrome (ACS) patients, according to a study presented at the American Heart Association's Scientific Sessions 2011 in Orlando, Fla., in mid-November.
Even though a new study did not show a correlation between pharmacist intervention and hospitalization and death rates for heart failure patients, the Heart Failure and Optimal Outcomes from Pharmacy Study (HOOPS) is an important study.
Recent FDA action (through December 2011) related to staccato loxapine, axitinib, mydicar, kalydeco, riboflavin ophthalmic solution, minocycline hydrochloride
Spending growth for specialty drugs rose 19.6% between 2009 and 2010, while growth of traditional drugs decreased by 1.4%, according to Express Scripts' 2010 Drug Specialty Report. Payers are struggling to appropriately manage high-cost drugs while ensuring their members get the care they need. One strategy is introducing a specialty drug tier to the formulary, which raises a red flag on access issues.
The 12th Asian Conference on Clinical Pharmacy will be held July 7-9, 2012, at the Hong Kong Convention and Exhibition Centre.
FDA’s Vaccines and Related Biologics Advisory Committee recently voted in favor of expanding the indication for the pneumococcal 13-valent conjugate vaccine (Prevnar 13) for the prevention of pneumococcal disease in adults age 50 years and older, Pfizer Inc, the drug’s manufacturer, said in a statement.
FDA approved the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets).
FDA approved zolpidem tartrate sublingual tablets (Intermezzo, Transcept Pharmaceuticals) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.
FDA has changed the label for fenofibric acid (Trilipix, Abbott). It now carries a warning that the agent may not lower the risk of myocardial infarction or stroke.
All children and adolescents should be screened for high cholesterol, and children as young as aged 10 should be considered for treatment with statins, according to the latest update from an expert panel convened by the National Heart, Lung, and Blood Institute.
The American Heart Association and American College of Cardiology Foundation have issued new guidelines for secondary prevention and risk reduction in patients with atherosclerotic vascular disease.
Some essential chemotherapy drugs are in short supply for the first time in the United States, according to the October 3 New England Journal of Medicine.
FDA is requiring that manufacturers of tumor necrosis factor blockers perform enhanced safety surveillance, the agency said on November 3 in an ongoing safety review of this class of biologic products.
FDA has approved aflibercept (Eylea Injection, Regeneron), known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) age-related macular degeneration in patients aged 60 and older at a recommended dose of 2 mg every 4 weeks (monthly) for the first 12 weeks, followed by 2 mg every 8 weeks (2 months).
FDA approved ruxolitinib (Jakafi, Incyte) for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.
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