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All News - Page 141
FDA Actions in Brief May 2012
June 1, 2012
Recent FDA Approvals (through May 2012) related to (Meda, Novo Nordisk, Janssen, Vivus, Clinigen, GlaxoSmithKline, Stride Arcolab)
Pipeline Preview
June 1, 2012
Recent FDA action (through May 2012) related to, Loxapine, Adasuve, Alexza Pharmaceuticals, Denosumab, Xgeva, Amgen, Furiex, Takeda, Nesina, alogliptin, fixed-dose combination alogliptin and pioglitazone, Liovel, Emtricitabine and tenofovir disoproxil fumarate, Truvada, Gilead Sciences, Lorcaserin, Arena Pharmaceuticals, Eisai, Tofacitinib, Pfizer, Tafamidis, ACH-3102, Achillion, CK-2017357, Cytokinetics, Taliglucerase alfa, Elelyso, Pfizer, Carisbamate, SK Biopharmaceuticals, Vancomycin hydrochloride, Vancocin, Akorn, Watson
New contraindications and modified cardiovascular parameters for fingolimod
June 1, 2012
On May 15, 2012, FDA announced completion of their safety review of fingolimod (Gilenya, Novartis).
Expansion paradigm of nonprescription drugs could improve efficiencies and access, but raises quality issues
June 1, 2012
As FDA considers a new paradigm that would expand the definition of nonprescription drugs, healthcare experts say the proposed paradigm could have its benefits and challenges for the healthcare industry.
Liposomal bupivacaine: A long-acting local anesthetic for postsurgical analgesia
June 1, 2012
A look at liposomal bupivacaine, a local anesthetic providing pain relief post-surgery
Omontys (Peginesatide): The first pegylated erythropoiesis-stimulating agent for the treatment of anemia due to CKD in adults undergoing dialysis
June 1, 2012
New molecular entity: FDA approved the synthetic, pegylated erythropoiesis-stimulating agent (ESA) peginesatide (Omontys, Affymax) for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
New models support comparative research, more nonprescription drugs
June 1, 2012
The drive for personalized medicine and greater patient involvement in treatment decisions demands more informative data on the effects and risks associated with drugs and medical products.
Management of chronic kidney disease: An emphasis on delaying disease progression and treatment options
June 1, 2012
Chronic kidney disease (CKD) remains a significant cause of morbidity and mortality. Here's a review of treatment options and guidelines to delay disease progression.
FDA again warns of dangers using benzocaine, especially in small children
May 31, 2012
The use of benzocaine gels and liquids to soothe teething and mouth and gum pain can lead to a rare but serious?and sometimes fatal?condition called methemoglobinemia, according to an FDA Consumer Update.
Senate passes FDA bill that could alleviate drug shortages
May 25, 2012
The drug-shortage crisis got a step closer to being alleviated Thursday, when the U.S. Senate passed FDA?s Safety and Innovation Act (SB-3187).
Atypical antipsychotics may help refractory depression
May 25, 2012
The use of atypical antipsychotics in patients with major depressive disorder who have not responded to antidepressant therapy substantially increased clinical response rates at 6 weeks; however the drugs are also much more costly, according to the results of an analysis published in the May issue of The Annals of Pharmacotherapy.
FDA completes safety review of MS drug
May 25, 2012
The multiple sclerosis drug fingolimod (Gilenya, Novartis) is now contraindicated for use in patients with certain pre-existing or recent heart conditions or stroke, or who are taking certain antiarrhythmic medications, according to FDA
Probiotics reduce antibiotic-associated diarrhea risk, study finds
May 25, 2012
Taking probiotics during a course of antibiotics reduces the risk of antibiotic-associated diarrhea, according to the results of a study published May 9 in the Journal of the American Medical Association.
CMS: Affordable Care Act continues to close "donut hole"
May 24, 2012
The Affordable Care Act saved Medicare recipients more than $3 billion on prescription drugs and 12.1 million recipients used a free preventive service in the first four months of 2012, the government said in a news release today
Study: Zithromax associated with cardiovascular deaths; FDA reviewing
May 18, 2012
FDA has notified healthcare professionals that it is aware of a study published in the New England Journal of Medicine reporting a small increase in cardiovascular deaths and in the risk of death from any cause in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug.
Warfarin, aspirin similar in treating heart failure
May 18, 2012
Warfarin fared no better than aspirin at reducing the combined risk of brain hemorrhage, stroke, or death for heart-failure patients in normal rhythm, according to the results of a study published in the New England Journal of Medicine.
Study on schizophrenia deaths makes surprising find
May 18, 2012
A unique study designed to gauge the impact of polypharmacy on schizophrenia mortality produced some surprising results: The use of antidepressants or 2 or more antipsychotics was not associated with increased deaths, but the use of benzodiazepine was.
Variation in schizophrenia treatment
May 18, 2012
Patients with schizophrenia who switched from haloperidol decanoate or fluphenazine decanoate to risperidone microspheres discontinued their treatment more frequently, according to a new study published in the March issue of the Journal of Clinical Psychiatry.
Vitamin D threshold varies with season, study shows
May 18, 2012
Researchers from the University of Washington have identified a threshold concentration of serum 25-hydroxyvitamin D [25-(OH)D] that is associated with increased risk for major medical events and they say that season-specific targets may be more appropriate than static targets when evaluating health risk.
FDA approves generic versions of blood thinner Plavix
May 17, 2012
FDA has approved generic versions of clopidogrel tablets USP (Plavix, Sanofi and Bristol-Myers Squibb), 75 mg and 300 mg.
Hospira recalls one lot of hydromorphone injection
May 14, 2012
Hospira is voluntarily recalling one lot of hydromorphone injection, USP, 1 mg/mL (C-II), 1-mL fill in 2.5-mL Carpuject, NDC 0409-1283-31, after complaints that a single Carpuject contained more than the 1-mL labeled fill volume, according to a press release posted on the FDA website.
FDA hears from stakeholders about biosimilar product development
May 14, 2012
Pharmacists need additional guidance on the handling of biosimilar products in the pharmacy when these products become more widely available following the approval of the biosimilar pathway, said Marcie Bough, senior director of government affairs, APhA, speaking at an FDA hearing last week.
FDA advisory committee supports first drug for HIV prevention
May 14, 2012
FDA?s Antiviral Drugs Advisory Committee has recommended approval of once-daily oral emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead Sciences) to reduce the risk of HIV-1 infection among uninfected adults.
Youth with type 2 diabetes at risk for add-on therapies
May 11, 2012
Youth diagnosed with type 2 diabetes may require a combination treatment or insulin therapy within a few years after diagnosis, according to a study published online April 29 in the New England Journal of Medicine.
Surgery and therapy improve type 2 diabetes, results show
May 11, 2012
Bariatric surgery plus medical therapy may be a useful strategy for managing uncontrolled diabetes, according to the results of a recent study published in the New England Journal of Medicine.
Study compares infection risk for JIA, ADHD patients
May 11, 2012
Children with juvenile idiopathic arthritis were at twice the risk of infection compared with children with attention-deficit hyperactivity disorder, according to a study published May 1 in Arthritis & Rheumatism.
Improvements in warfarin therapy reduce stroke rate, study shows
May 11, 2012
Current use of warfarin as a stroke prevention therapy in patients with nonvalvular atrial fibrillation is associated with a lower rate of residual stroke or systemic embolism compared with previous data, according to a recent study published in the Archives of Internal Medicine.
FDA revises finasteride labels
May 4, 2012
"The labels of 2 formulations of finasteride, used to treat enlarged prostate and male-pattern baldness, are being revised to indicate that additional sexual side effects may persist after the drug has been discontinued, FDA announced"
Omega-3 shows no benefit for multiple sclerosis, study finds
May 4, 2012
The supplementation with omega-3 fatty acids has no benefit in treating multiple sclerosis, according to a clinical trial that appeared in the JAMA?s Archives of Neurology. However, researchers acknowledged the randomized controlled trial was underpowered.
