Formulary Watch |
All News - Page 140
FDA issues complete response letter for ACS indication for rivaroxaban
June 22, 2012
FDA issued a complete response letter regarding a supplemental New Drug Application for rivaroxaban (Xarelto, Janssen Research & Development) for the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome.
AMCP pleased with revised PDUFA
June 22, 2012
The Academy of Managed Care Pharmacy strongly favors the revisions of the Prescription Drug User Fee Act (PDUFA) that the US House of Representatives and the US Senate conference committee negotiated earlier this week and the House passed by voice vote on Wednesday.
Dabigatran prescribing information is updated
June 22, 2012
Label prescribing information for dabigatran (Pradaxa, Boehringer Ingelheim) capsules has been updated to affirm that the 150-mg twice-daily dose is superior to warfarin in reducing ischemic and hemorrhagic strokes in patients with nonvalvular atrial fibrillation.
Ongoing diabetes self-management support study
June 22, 2012
A participant-driven reinforcement program for diabetes self-management education can have a positive effect on self-care behaviors as well as metabolic and cardiovascular health, according to a study published recently in Preventing Chronic Disease.
MTX injection not superior to oral administration in juvenile idiopathic arthritis
June 22, 2012
Injections of methotrexate were not superior to oral therapy in long-term treatment of patients with juvenile idiopathic arthritis, according to a new study, published in the May 30 online edition of Arthritis Care & Research.
Combination therapy more effective than metformin alone for treating youth with type 2 diabetes
June 22, 2012
A combination of 2 diabetes drugs, metformin and rosiglitazone (Avandia, GlaxoSmithKline), was more effective in treating youth with recent-onset type 2 diabetes than metformin alone, a study funded by the National Institutes of Health has found.
Congress moves promptly to finalize FDA user fees
June 19, 2012
House and Senate leaders announced final agreement June 18 on legislation that authorizes industry user fees to support FDA regulatory programs.
Report blames FDA for drug shortage crisis; FDA defends its enforcement actions
June 18, 2012
Republicans in the House of Representatives have published a report blaming the current increase in drug shortages mostly on FDA under the current administrator.
FDA approves first combination vaccine to help prevent meningococcal serogroups C and Y and Hib disease
June 15, 2012
FDA has approved the first combination vaccination for use in children aged 6 weeks through 18 months for the prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenza type b, according to an FDA statement.
New data shows better QOL with enzalutamide for men with advanced prostate cancer
June 15, 2012
Men with advanced prostate cancer treated with investigational enzalutamide (formerly MDV3100) demonstrated a significantly higher response rate in health-related quality of life compared with placebo, according to new data from the phase 3 AFFIRM study.
Afatinib used in lung cancer treatment helps patients live longer, results show
June 15, 2012
Investigational afatinib used in non-small cell lung cancer treatment helped patients live longer compared with pemetrexed/cisplatin, according to the results of a new phase 3 clinical trial.
NSAIDs may prevent skin cancer, study suggests
June 15, 2012
Nonsteroidal anti-inflammatory drugs may prevent the development of skin cancer, according to a new study, published online first in the journal Cancer on May 29.
Study: Unintentional overdose on OTC acetaminophen linked to limited literacy, heavy usage
June 15, 2012
In a recent study, researchers find reasons why a significant number of US adults are at risk of unintentionally overdosing on over-the-counter pain medications.
Daily vitamin D, calcium supplementation in postmenopausal women no longer recommended for prevention of fractures, USPSTF says
June 13, 2012
Daily vitamin D (≤400 IU) and calcium (1,000 mg) supplements for the primary prevention of fractures in postmenopausal women are no longer recommended as they don’t help prevent fractures and may cause harm, according to draft guidance from the US Preventive Services Task Force.
FDA approves pertuzumab for treatment of HER2-positive metastatic breast cancer
June 11, 2012
FDA has approved pertuzumab (Perjeta, Roche) in combination with trastuzumab (Herceptin) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
FDA approves Horizant for postherpetic neuralgia indication
June 8, 2012
FDA has approved gabapentin enacarbil (Horizant, GlaxoSmithKline and XenoPort) extended-release tablets for the management of postherpetic neuralgia in adults.
US needs registry for naming biosimilars, author says
June 8, 2012
The industry should collaborate to develop a US Biopharmacopeia Registry of Biopharmaceutical Products to help resolve biosimilar and broader biopharmaceutical nomenclature issues, according to a leading author and publisher.
Intensive blood-sugar control for diabetic patients produces mixed results
June 8, 2012
Intensive control of blood-sugar levels among patients with type 2 diabetes mellitus may reduce the risk of microalbuminuria and macroalbuminuria, signs of kidney damage, but evidence is lacking regarding the effect over renal end points, according to the results of a study published May 28 in Archives of Internal Medicine.
CMS wants to reduce use of antipsychotics for dementia
June 8, 2012
The Centers for Medicare and Medicaid Services is partnering with providers, caregivers, and patients to ensure appropriate use of antipsychotic medications for nursing home patients, the government announced last week.
CDC proposes expansion of hepatitis C guidelines
June 8, 2012
The Centers for Disease Control and Prevention is proposing an expansion of its current hepatitis C risk-based guidelines to include a simple, one-time blood test for anyone born from 1945 through 1965.
Sandoz recalls some lots of generic Introvale due to packaging error
June 7, 2012
Sandoz, a division of Novartis, is voluntarily recalling 10 lots of its generic oral contraceptive Introvale (levonorgestrel and ethinyl estradiol) tablets in the United States, after a consumer reported a packaging flaw.
HHS harnesses the power of health data to improve health
June 5, 2012
The Health Data Initiative Forum III: The Health Datapalooza cohosted by the Institute of Medicine and the US Department of Health and Human Services (HHS) is convening this week in Washington, DC, focusing on innovative applications and services that harness the power of open data from HHS and other sources to help improve health and healthcare.
FDA user fee legislation heads toward finish line
June 1, 2012
Legislation to reauthorize FDA user fee programs sailed through the House and Senate last month, setting the stage for leading legislators to resolve their differences and agree on a compromise measure. Much of the work will be tackled by committee staffers who have been laboring over the legislative details for months. The aim is to bring the House and Senate leaders together in about 2 weeks to hash out the final language.
Study: Increase in e-prescribing helps adherence, costs
June 1, 2012
The number of physicians and clinicians using e-prescribing increased by 67% in 2011 and they filled 75% more medication orders electronically, according to a new downloadable report by Surescripts, which operates a nationwide network connecting the computer systems of physicians and pharmacies.
Folic acid supplementation may lower risk of certain childhood cancers
June 1, 2012
Folic acid fortification of US grain products may be lowering rates of certain kidney and brain cancers in children but does not appear to be causing childhood cancer rates to increase, according to findings from a study published online May 22 in the journal Pediatrics.
Statin therapy may benefit low-risk patients
June 1, 2012
Statin therapy is safe and effective for people at low risk of major vascular events and, therefore, current guidelines might need to be reconsidered, according to a study published online in The Lancet.
Many diabetes patients don't receive recommended first-line drug
June 1, 2012
More than a third of patients newly diagnosed with type 2 diabetes mellitus did not receive the recommended first-line drug, a finding that could have substantial implications for healthcare spending, according to a study published in the American Journal of Medicine.
Post-PCI bleeding reduced with changes in strategy
June 1, 2012
Changes in procedural antithrombotic strategy are associated with a significant temporal reduction in major bleeding over time in patients undergoing elective post-percutaneous intervention, according to a study published in the Journal of the American College of Cardiology.
Surfaxin (Lucinactant): An intratracheal suspension indicated for the prevention of respiratory distress syndrome in premature infants
June 1, 2012
New molecular entity: FDA approved lucinactant (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk of RDS.
