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All News - Page 172
FDA actions in brief, October 2009 (Sabril, Helixate FS, Valcyte, Metozolv ODT, Xyzal, Zevalin, Extavia, Astepro, Zenpep, Bepreve)
October 1, 2009
Recent FDA approvals (through October 2009) related to Sabril, Helixate FS, Valcyte, Metozolv ODT, Xyzal, Zevalin, Extavia, Astepro, Zenpep, and Bepreve
FDA leadership promotes scientific integrity, quality standards
October 1, 2009
FDA officials are taking steps to erase the charges of incompetency and ineffectiveness that have plagued the agency for several years.
Morphine/naltrexone extended-release capsules (Embeda): Combination of mu-opioid agonist and mu-opioid antagonist approved for the management of moderate-to-severe pain when continuous analgesia is needed for an extended time period
October 1, 2009
New combination: Morphine/naltrexone extended-release capsules (Embeda) were approved on August 13, 2009, for the management of moderate-to-severe pain when continuous analgesia is needed for an extended time period
FDA Pipeline preview, October 2009 (doxorubicin, trabectedin, carisbamate, alogliptin/pioglitazone, HPV vaccine, pralatrexate, romidepsin, hyaluronic acid, laromustine, clofarabine, prGCD, KNS-760704, rifaximin, hexvix, quinazoline495)
October 1, 2009
Recent FDA action (through October 2009) related to doxorubicin, trabectedin, carisbamate, alogliptin/pioglitazone, HPV vaccine, pralatrexate, romidepsin, hyaluronic acid, laromustine, clofarabine, prGCD, KNS-760704, rifaximin, hexvix, and quinazoline495
First-time generic drug approvals, October 2009
October 1, 2009
Generic drugs approved by FDA (through October 2009): 1% clindamycin/5% benzoyl peroxide gel, triamcinolone acetonide nasal spray, clonidine transdermal system, betamethasone acetate and betamathasone sodium phosphate injectable suspension
Guanfacine extended-release tablets (Intuniv): Selective alpha2a-adrenergic receptor agonist approved for the treatment of ADHD
October 1, 2009
New formulation: Guanfacine extended-release tablets (Intuniv) were approved on September 2, 2009, for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Telavancin for injection (Vibativ): Lipoglycopeptide antibiotic approved for the treatment of complicated skin and skin-structure infections
October 1, 2009
New molecular entity: Telavancin for injection (Vibativ) was approved on September 11, 2009, for the treatment of complicated skin and skin-structure infections (cSSSIs)
Fampridine-SR: A potassium-channel blocker for the improvement of walking ability in patients with MS
October 1, 2009
Fampridine-SR is a sustained-release oral medication that is pending FDA approval for the symptomatic treatment of multiple sclerosis (MS).
Specialty pharmacy's role in REMS, FDA's new drug safety program
October 1, 2009
Specialty pharmacies are uniquely positioned to play a key role in the implementation of Risk Evaluation and Mitigation Strategies (REMS).
Leukotriene inhibitors associated with neuropsychiatric events
September 14, 2009
In an update to an earlier communication, FDA announced that the manufacturers of the leukotriene inhibitors montelukast (Singular), zafirlukast (Accolate), zileuton (Zyflo), and zileuton extended-release (Zyflo CR) are adding information about neuropsychiatric events to product labeling.
Mycophenolic acid associated with increased risk of pure red cell aplasia
September 14, 2009
Novartis has issued a Dear Healthcare Professional letter regarding a risk of pure red cell aplasia (PRCA) in patients treated with mycophenolic acid (Myfortic).
FDA issues early communication about ongoing safety review of orlistat
September 14, 2009
FDA is reviewing reports of liver injury in patients treated with orlistat (prescription drug, Xenical; OTC drug, Alli) for obesity management or weight loss.
Etravirine associated with severe skin and hypersensitivity reactions
September 14, 2009
Tibotec has issued a Dear Healthcare Professionals letter regarding an increased risk of fatality caused by toxic epidermal necrolysis and hypersensitivity reactions, sometimes accompanied by hepatic failure, in patients treated with etravirine (Intelence).
Medication interventions get a boost from a powerful tool
September 14, 2009
Pharmacists can improve patient outcomes by following 3 major functions: identification of potential and actual medication-related problems (MRPs), resolution of actual MRPs, and prevention of potential MRPs. The best way to achieve these goals is through accurate documentation, and one of the chief obstacles to this is time?or rather the lack of it. Various software programs have been developed to help pharmacists reduce time spent identifying opportunities for interventions.
Perioperative fluvastatin treatment associated with improved CV outcome after noncardiac vascular surgery
September 14, 2009
In the Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography III (DECREASE III) trial published in the New England Journal of Medicine, patients undergoing noncardiac vascular surgery who were treated with perioperative fluvastatin demonstrated a lower incidence of myocardial ischemia than patients treated with placebo.
Ticagrelor associated with lower rate of death from vascular causes, MI, and stroke
September 14, 2009
In the Study of Platelet Inhibition and Patient Outcomes (PLATO) published in the New England Journal of Medicine, patients with acute coronary syndrome (ACS) who were treated with ticagrelor had significant reductions in the rate of death from vascular causes, myocardial infarction (MI), or stroke and no significant increase in the rate of overall major bleeding versus patients treated with clopidogrel.
Formulary Digital Edition September 2009
September 1, 2009
P&T considerations in fashioning a knowledge base, action plan for cardiometabolic disorders and weight; Focus on golimumab; Drug Watch: Agents in late-stage development for the treatment of gastrointestinal disorders
Global health concerns generate new therapies for home and abroad
September 1, 2009
Even before the emergence of the swine flu pandemic, biopharmaceutical companies were investing in vaccines and treatments for lethal diseases that plague much of the world. There is growing recognition that Americans and Europeans are vulnerable to infections from overseas, and that development of new medications is critical to ensuring public health.
Bevacizumab (Avastin): Monoclonal antibody approved for the treatment of metastatic renal cell carcinoma in combination with interferon alfa
September 1, 2009
New indication: Bevacizumab (Avastin), a monoclonal antibody, was approved on July 31, 2009, for the treatment of metastatic renal cell carcinoma in combination with interferon alfa
First-time generic drug approval, September 2009: Tacrolimus capsules
September 1, 2009
Generic drug approved by FDA (through September 2009): tacrolimus capsules
P&T considerations in fashioning a knowledge base, action plan for cardiometabolic disorders and weight
By Mari Edlin
September 1, 2009
The P&T committee is positioned to provide knowledge, strategies to improve treatment of patients with cardiometabolic disorders.
FDA actions in brief, September 2009 (Saphris, Tracleer, Livalo, Tyvaso, Tekturna HCT, Onsolis, Forteo, Invega Sustenna, Colcrys, Acuvail, Lipsovir, Kogenate FS)
September 1, 2009
Recent FDA approvals (through September 2009) related to Saphris, Tracleer, Livalo, Tyvaso, Tekturna HCT, Onsolis, Forteo, Invega Sustenna, Colcrys, Acuvail, Lipsovir, and Kogenate FS
Saxagliptin (Onglyza): DPP-4 inhibitor approved for the treatment of type 2 diabetes mellitus
September 1, 2009
New molecular entity: Saxagliptin (Onglyza), a DPP-4 inhibitor, was approved on July 31, 2009, for the treatment of type 2 diabetes mellitus
Sumatriptan (Sumavel DosePro): Needle-free injection of 5-HT1 receptor agonist approved for the acute treatment of migraine and cluster headaches
September 1, 2009
New formulation: Sumatriptan (Sumavel DosePro) formulated as a needle-free injection was approved on July 15, 2009, for the acute treatment of migraine and cluster headaches
FDA Pipeline preview, September 2009 (cethromycin, pegloticase, guanfacine, denosumab, apaziquone, TZP-102, beclomethasone 17,21-dipropionate)
September 1, 2009
Recent FDA action (through September 2009) related to cethromycin, pegloticase, guanfacine, denosumab, apaziquone, TZP-102, and beclomethasone 17,21-dipropionate
Golimumab: A human anti-TNF-alpha monoclonal antibody for the treatment of autoimmune joint diseases
September 1, 2009
Golimumab is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody that was recently approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
Drug Watch: Agents in late-stage development for the treatment of gastrointestinal disorders (September 2009) (PDF)
September 1, 2009
Agents in late-stage development for the treatment of Crohn's disease, ulcerative colitis, irritable bowel syndrome, and short bowel syndrome
Trial of sildenafil for PAH in patients with sickle cell disease terminated because of safety concerns
August 18, 2009
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has prematurely terminated a trial of sildenafil for the treatment of pulmonary arterial hypertension (PAH) in adult patients with sickle cell disease because of safety concerns.
New warnings about malignancies in pediatric patients added to labels of TNF-blockers
August 18, 2009
After completing an analysis of safety data for tumor necrosis factor (TNF)-blockers, FDA has stated that there is an increased risk of lymphoma and other cancers in pediatric patients who are treated with these agents.
