Formulary Watch |
All News - Page 143
FDA approves tablets for adult patients with type 2 diabetes
February 6, 2012
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.
FDA approves update to Gleevec label, extending treatment to certain GIST patients
February 6, 2012
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 approves extended-release tablets for type 2 diabetes
February 3, 2012
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, healthcare facilities urged to require staffs to get flu shots
February 3, 2012
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 approves vismodegib for treating basal cell skin cancer
February 3, 2012
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.
ACP groups will used cloud-based system for diabetes project
February 3, 2012
State chapters of the American College of Physicians will soon begin a diabetes pilot project using a cloud-based health system.
High-normal BP in middle-aged men linked to atrial fibrillation later in life
February 3, 2012
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.
ASSERT links pacemakers with increased risk of ischemic stroke
February 3, 2012
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.
Study: Furosemide-induced high urine output reduces risk of CIN
February 3, 2012
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 approves Bydureon, first once-weekly treatment for type 2 diabetes
February 2, 2012
FDA has approved exenatide extended-release for injectable suspension (Bydureon, Amylin and Alkermes) ? the first once-weekly treatment for type 2 diabetes.
American Academy of Neurology and International League against Epilepsy release guidelines for the use of antiepileptic drugs in patients with HIV/AIDS
February 1, 2012
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).
AMERICAN COLLEGE OF RHEUMATOLOGY: Tocilizumab responses durable to 2 years in juvenile idiopathic arthritis
February 1, 2012
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.
FDA Actions in Brief February 2012 (BTG International, Biogen Idec, Elan, Pfizer, Gilead, INSYS Therapeutics, Takeda, CSL Behring)
February 1, 2012
Recent FDA Approvals (through January 2012) related to (BTG International, Biogen Idec, Elan, Pfizer, Gilead, INSYS Therapeutics, Takeda, CSL Behring)
FDA adverse drug events app for public health crises could expand to more general adverse event reporting
February 1, 2012
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.
FDA modifies REMS for 2 platelet-booster drugs
February 1, 2012
In December, FDA announced changes to Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs romiplostim (Nplate) and eltrombopag (Promacta).
Health reform promises expanded drug coverage through ACOs, exchanges, value-based initiatives
February 1, 2012
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.
FDA advisory panel recommends stronger warning for drospirenone-containing birth control
February 1, 2012
An FDA advisory panel has recommended that some oral contraceptives may need stronger warning labels, according to recent reports.
Rivaroxaban reduces combined risk of cardiovascular death, myocardial infarction, or stroke in ACS patients
February 1, 2012
An estimated 1.2 million Americans are discharged from a hospital with a diagnosis of acute coronary syndrome (ACS) each year. Now, a new randomized controlled trial dubbed "ATLAS ACS 2" (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome), is suggesting rivaroxaban may reduce the risk of the composite end point of death from cardiovascular causes, myocardial infarction, or stroke in patients with a recent ACS, but at a cost of increased major bleeding.
Aflibercept (Eylea): A monthly intravitreal injection for wet age-related macular degeneration (AMD)
February 1, 2012
New molecular entity: Aflibercept once-monthly intravitreal injection is FDA approved to treat patients with wet (neovascular) age-related macular degeneration.
Treatment response to antidepressants similar in MDD patients with and without medical comorbidities
February 1, 2012
In patients with major depressive disorder (MDD) and general medical conditions, the use of antidepressants was safe and effective compared to patients without such conditions. Combination therapy was no different than monotherapy, regardless of the number of comorbidities present, according to the recent findings of a new randomized, single-blind, placebo-controlled trial published in The Annals of Family Medicine.
Immunization update: A 2011 retrospective on product changes and new recommendations
February 1, 2012
Vaccines are one of the greatest achievements of biomedical science and public health. Proper vaccination plays a critical role in the reduction of vaccine-preventable disease and related morbidity and mortality.
Most would reserve rivaroxaban as second-line therapy for patients with chronic atrial fibrillation
February 1, 2012
Respondents to a Formulary readers' poll would reserve the use of newly approved rivaroxaban (Xarelto, Janssen) for the management of chronic atrial fibrillation (AF) to those patients who have contraindications to warfarin, had unmanageable side effects to warfarin, or in whom warfarin was ineffective.
Zolpidem tartrate (Intermezzo): First insomnia therapy for middle-of-the-night waking followed by difficulty returning to sleep
February 1, 2012
New indication: FDA approved Zolpidem tartrate sublingual tablets or the treatment of insomnia characterized by middle-of-the-night (MOTN) wakening followed by difficulty returning to sleep.
Orally inhaled dihydroergotamine: A novel ergot delivery method for the treatment of migraine
February 1, 2012
Orally inhaled dihydroergotamine (DHE) is a newly developed formulation of DHE for the treatment of acute migraine attack and is undergoing FDA review.
Hospital-acquired C. difficile lengthens hospital stay, retrospective study shows
February 1, 2012
Hospital-acquired Clostridium difficile significantly prolongs the duration of a patient's stay in the hospital by at least 6 days, according to the findings of a study published online December 5, for the Canadian Medical Association Journal.
AMERICAN COLLEGE OF RHEUMATOLOGY: More than one-fourth of rheumatoid arthritis patients respond to methotrexate-first strategy
February 1, 2012
Methotrexate alone, with step up to other therapies only if a response is not achieved, is a reasonable starting strategy for treating "poor prognosis" rheumatoid arthritis (RA), said James O'Dell, MD, at the annual scientific meeting of the American College of Rheumatology, Chicago.
Romiplostim induces rapid platelet response in adult patients with immune thrombocytopenia
February 1, 2012
Romiplostim (Nplate, Amgen), a synthetic protein that binds to and stimulates the thrombopoietin receptor, induced a rapid platelet response in most adult patients with immune thrombocytopenia (ITP) who had low platelet counts or bleeding symptoms, regardless of splenectomy status.
FDA Pipeline Preview, February 2012 (Bristol-Myers Squibb, AstraZeneca, Columbia Laboratories, Watson Pharmaceuticals, Achillion, Catalyst Pharmaceutical Partners, AlloCure, Neurocrine Biosciences, AiCuris, CanBas, Pinnacle Biologics, Ikaria)
February 1, 2012
Recent FDA action (through January 2012) related to dapagliflozin, progesterone vaginal gel 8%, ACH-1625 protease inhibitor, CPP-115 GABA aminotransferase inhibitor, AC607, NBI-98854 VMAT2 inhibitor, AIC246 inhibitor, CBP501, Porfimer sodium, inhaled nitric oxide, carbamazepine extended-release capsules, levetiracetam extended-release tablets
