News

FDA has approved vilazodone HCl tablets (Viibryd, Clinical Data) for the treatment of adults with major depressive disorder.

FDA approved spinosad (Natroba, ParaPRO LLC) Topical Suspension 0.9% for the treatment of head lice infestation in patients aged 4 years and older.

With the healthcare reform law repeal exercise behind them, Congressional leaders can get down to focusing on ways to eliminate or repair some of the more contentious reform provisions and to modify others, according to policy watchers.

FDA has sent MannKind Corp. a complete response letter regarding the company?s NDA for Afrezza Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia.

Concern that its potential clot-preventing drug vorapaxar increased the risk of bleeding in stroke victims has prompted Merck & Co. to halt a late-stage study of the drug, the Associated Press reported.

Elderly patients have difficulty with long-term adherence to medications following myocardial infarction, and this is significantly worse among those with kidney dysfunction, according to a study published online January 13 in the Clinical Journal of the American Society of Nephrology, HealthDay News reported.

Antiepileptic drugs may increase the risk of nontraumatic fractures in patients aged 50 years and older, according to a study published in the January issue of the Archives of Neurology, HealthDay News reported.

A combination drug therapy given initially appears to result in better blood pressure control in individuals compared with those who are treated with monotherapy, according to research published online January 13 in The Lancet, HealthDay News reported. Those who underwent the 2-drug treatment after taking the single-drug therapy also experienced better blood pressure outcomes, though not at the same level as those who began with the combination treatment.

Commonly used nonsteroidal anti-inflammatory drugs may increase the risk of heart attack, stroke, and death, according to a meta-analysis published January 11 in British Medical Journal, HealthDay News reported.

A 2-week course of rifaximin (Xifaxan, Salix Pharmaceuticals) relieved bloating and other symptoms of irritable bowel syndrome for more than 2 months after treatment ended, according to research published January 6 in the New England Journal of Medicine. Rifaximin is the first treatment that targets the underlying cause of IBS, rather than just treating the symptoms, researchers said.

FDA has approved the premix formulation of vancomycin injection, USP (750 mg/150 mL) (Baxter). Vancomycin is an antibiotic used to treat severe infections caused by susceptible strains of methicillin-resistant Staphylococcus aureus and/or treat patients who are penicillin-resistant.

Severe liver injury, including 2 cases of acute liver failure leading to liver transplant in patients treated with the medication, has been associated with the use of dronedarone (Multaq), according to an FDA Drug Safety Communication announcement.

Blue Cross Blue Shield of Massachusetts (BCBSMA) has announced a new community partner strategy that will focus on four key areas: healthy child development, education enrichment, healthy environments and family nutrition, and sustainable health care.

With new electronic medical records (EMR) rules taking effect by 2012 and the technology becoming necessary by 2015 for practices to receive tax benefits and subsidies, health plans are assessing their role in the electronic exchange of healthcare information.

The Association of Community Cancer Centers (ACCC) has released a study of how ? and how well ? the cancer patient's transition from the hospital inpatient setting to outpatient oncology group is managed.

CVS Caremark Corporation, the second-largest drugstore chain in the U.S., plans to acquire the Medicare Prescription Drug business of Universal American for about $1.25 billion.

Severe liver injury, including 2 cases of acute liver failure leading to liver transplant in patients treated with the medication, has been associated with the use of dronedarone (Multaq), according to an FDA Drug Safety Communication announcement.

FDA has approved a label update to include a 200-mg formulation of etravirine (Intelence, Tibotec Therapeutics), a non-nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV-1 in adults resistant to an NNRTI and other antiretroviral agents.

Twenty-four-day oral contraceptive regimens containing a progestogen with a long half-life shows higher contraceptive effectiveness under routine medical conditions compared with conventional 21-day regimens, according to research published in the January 2011 issue of Obstetrics & Gynecology.

FDA has approved fentanyl (Abstral, ProStraken) transmucosal tablets to manage breakthrough pain for adults with cancer. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gum, tongue), or the nasal passages or throat where they dissolve and are absorbed.

The Infectious Diseases Society of America is set to release its first guidelines for the treatment of the increasingly common and potentially deadly methicillin-resistant Staphylococcus aureus infection.

The impact of generic drugs-which now account for more than 70% of all prescriptions dispensed in the United States-will continue to increase as some of the world's most-prescribed products lose their patent protection in 2011 and begin facing generic competition.

FDA is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule.

FDA has approved fentanyl (Abstral, ProStraken) transmucosal tablets to manage breakthrough pain for adults with cancer.

In a guest editorial, 2 researchers highlighted the importance of the FDA approval in October of dabigatran etexilate (Pradaxa, Boehringer Ingelheim), an oral thrombin inhibitor that provides an alternative to warfarin (Coumadin, Bristol-Myers Squibb) for long-term stroke prevention in patients with non-valvular atrial fibrillation.

The addition of bortezomib to the standard induction therapy before double autologous stem cell transplantation for patients with multiple myeloma appears to improve nearly threefold the rates of complete or near complete response, according to research published online in The Lancet, HealthDay News reported.

Patients who are newly treated with statin-fibrate concurrent therapy are slightly more likely to be hospitalized with rhabdomyolysis than those who take just one of the medications, according to research published in the American Journal of Cardiology, HealthDay News reported.

Many serious or potentially fatal adverse reactions associated with new, targeted anticancer agents are not reported in the original published research on the drug, and they are not known to oncologists until years later when updated drug labels, including boxed warnings, are required, according to research published online in the Journal of Clinical Oncology, HealthDay News reported.