Formulary Watch

FDA has approved mitomycin (Mitosol, Mobius Therapeutics) for use in glaucoma surgery.

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

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.

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.

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.

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

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

FDA has granted priority review to crofelemer 125-mg tablets (Salix Pharmaceuticals) for the control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (ART).

FDA has approved (linagliptin/metformin hydrochloride (Jentadueto, Boehringer Ingelheim and Eli Lilly) tablets, which combine the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. Jentadueto provides a new, single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar.

Following a priority review, FDA has approved an update to imatinib mesylate (Gleevec, Novartis) tablets? label to recommend 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) who met the risk of recurrence inclusion criteria of the pivotal trial.

FDA approved sitagliptin and metformin hydrochloride (HCl) extended-release (Janumet XR, Merck) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin.

Hospitals and healthcare facilities should require all employees to get an annual flu shot, a group representing many of the nation?s largest employers emphasized again at a press conference Wednesday in Washington, DC.

FDA has approved vismodegib (Erivedge, Curtis and Genentech, a member of the Roche Group) for the treatment of adult patients with basal cell carcinoma, the most common type of skin cancer.

State chapters of the American College of Physicians will soon begin a diabetes pilot project using a cloud-based health system.

Upper-normal blood pressures in otherwise healthy middle-aged men are long-term predictors of incident atrial fibrillation in older age, according to a study that appeared online January 17 in Hypertension.

Sub-clinical atrial tachyarrhythmias without clinical atrial fibrillation occurred frequently in patients with pacemakers and were associated with a significantly increased risk of ischemic stroke or systemic embolism, according to a recent study.

Furosemide-induced high urine output with matched hydration significantly reduced the risk of contrast-induced nephropathy in patients with chronic kidney disease undergoing a coronary procedure, according to a new study.

FDA has approved exenatide extended-release for injectable suspension (Bydureon, Amylin and Alkermes) ? the first once-weekly treatment for type 2 diabetes.

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Cardiovascular agents

Clinicians are urged to be cautious when selecting an antiepileptic drug (aeD) for patients with HIV/AIDS, according to new evidence-based guidelines developed by the American Academy of Neurology (AAN) and the International League Against Epilepsy (ILae).

In patients with severe, refractory, persistent systemic juvenile idiopathic arthritis (JIA), long-term treatment with tocilizumab induces significant, durable responses with acceptable toxicity, according to results from a multicenter phase 3 trial presented at the annual scientific meeting of the American College of Rheumatology, Chicago.

Recent FDA Approvals (through January 2012) related to (BTG International, Biogen Idec, Elan, Pfizer, Gilead, INSYS Therapeutics, Takeda, CSL Behring)

Prompted by the 2009 H1N1 influenza outbreak, FDA has announced plans to create a mobile app that will help it gather information and send out alerts about adverse reactions to experimental medications prescribed during public health crises.

In December, FDA announced changes to Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs romiplostim (Nplate) and eltrombopag (Promacta).

Last month, economists in the Department of Health and Human Services (HHS) reported a big slow-down in healthcare spending for 2010. Outlays rose only 3.9% to $2.6 trillion, largely because the recession and unemployment reduced healthcare coverage and prompted people to skip doctor visits. Spending on prescription drugs increased at a record low 1.2% to $259.1 billion, as utilization stagnated, more generics replaced old blockbusters, and fewer new drugs came on the market.