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Diabetes drug dapagliflozin fails to get approval from FDA

February 10, 2012

FDA declined approval of the diabetes drug dapagliflozin (Bristol-Myers Squibb and AstraZeneca), based on the recommendations of one of its advisory committees.

Study: Emergency visits increase risk of infections for long-term care residents

February 10, 2012

There was an increased risk of acute infection among long-term care residents who visited hospital emergency departments, according to a study published online January 23 in the Canadian Medical Association Journal.

Researchers warn of IV acetaminophen dosing errors

February 10, 2012

Researchers are warning pediatricians, pediatric hospitalists and intensivists of the potential for intravenous acetaminophen dosing errors, especially in young patients under 2 years old.

FDA panel votes against wider use of denosumab for prostate-cancer patients

February 10, 2012

An FDA advisory panel recommended against using denosumab (Xgeva, Amgen) to delay or prevent the spread of castration-resistant prostate cancer at risk for bone metastases.

Single-tablet option approved for treatment of adults with type 2 diabetes

February 10, 2012

FDA has approved linagliptin/metformin hydrochloride (Jentadueto, Boehringer Ingelheim and Eli Lilly) tablets, a new tablet that provides a single-tablet treatment option, taken twice-daily, for adult patients who need to control their blood sugar.

SSRIs increase risk of falls, injuries for elderly patients with dementia

February 10, 2012

Nursing home residents with dementia who use average doses of selective serotonin reuptake inhibitors (SSRIs) are three times more likely to have a fall resulting in injury compared with those who don’t use SSRIs, according a study published online January 18 in the British Journal of Clinical Pharmacology

Inlyta approved by FDA to treat renal cell carcinoma

February 10, 2012

FDA approved axitinib (Inlyta, Pfizer) to treat patients with an advanced kidney cancer called renal cell carcinoma who have not responded to another drug for this type of cancer.

FDA issues 3 draft guidances on biosimilars

February 10, 2012

FDA has issued 3 draft guidances for the development of biosimilar versions of approved biologic products, which will help flesh out the abbreviated approval pathway created by the Patient Protection and Affordable Care Act signed into law in 2010

FDA approves first gel for short-term topical AK therapy

January 27, 2012

FDA approved ingenol mebutate (Picato, LEO Pharma) gel (0.015%, 0.05%) for the topical treatment of actinic keratosis (AK). It is the first topical AK therapy that can be used for as few as 2 or 3 consecutive days.

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