Agents in late-stage development for the treatment of multiple sclerosis.
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Attention deficit hyperactivity disorder: More than a child's disorder; Focus on lurasidone; Agents in late-stage development for the treatment of multiple sclerosis
Lurasidone, a new-generation atypical antipsychotic, has been approved by FDA for the treatment of schizophrenia and is under investigation for the treatment of bipolar disorder. This article will discuss the clinical pharmacology, clinical trials, adverse events, drug interactions, dosing and administration, and formulary considerations.
This article will discuss the diagnosis and treatment of ADHD in adults including stimulant therapy, education and psychosocial intervention, and nonstimulant alternatives.
New combination: Aliskiren and amlodipine (Tekamlo) have been recently approved by FDA as an initial therapy to treat hypertension in patients likely to need multiple drugs to achieve their blood pressure goals, in hypertensive patients not adequately controlled with monotherapy, or as a substitute for its individual components.
The protease inhibitors boceprevir and telaprevir, in phase 3 development, are poised to become a new therapeutic category of medications to be added to the current standard of care to increase sustained virologic response rates and prevent liver disease in patients with hepatitis C.
Recent FDA Approvals (through October 2010) related to Latuda, Ofirmev, Cymbalta, Botox, Pradaxa, Afinitor, Teflaro, Herceptin, Kapvay
New combination: Olmesartan medoxomil, amlodipine, and hydrochlorothiazide (Tribenzor) have been recently approved by FDA as an initial therapy to treat hypertension in patients likely to need multiple drugs to achieve their blood pressure goals.
PCORI now has a chairman and board representing all stakeholders to take on the daunting task of setting the national CER agenda, developing systems for funding research, establishing standards and methods for comparative studies, and devising programs to disseminate results to practitioners and to the public.
Generic drugs approved by FDA (through October 2010): Extended-release suspension containing hydrocodone polistirex and chlorpheniramine polistirex
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Recent FDA action (through, October 2010) related to Qnexa, Linjeta, JZP-6, Bydureon, Zalbin, Staccato loxapine, Tapentadol extended-release oral analgesic, AVP-21D9, 1% tenofovir vaginal gel, AFM 13, hGH-CTP, Rozrolimupab, Nefecon, SB1518 JAK2 inhibitor.
FDA has issued a complete response letter (CRL) for lorcaserin's (Arena and Eisai) New Drug Application. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in some patients who are obese or patients who are overweight (and have at least 1 weight-related co-morbid condition.
OnabotulinumtoxinA (Botox, Allergan) has been approved by FDA as prophylactic treatment of headaches in adults with chronic migraine. It is the first clinically studied prophylactic treatment to receive FDA approval specifically for this debilitated patient population.
Bromfenac ophthalmic solution (Bromday, ISTA Pharmaceuticals) 0.09% has been granted FDA approval as a once-daily prescription eyedrop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
Dabigatran etexilate (Pradaxa, Boehringer Ingelheim) has received FDA approval for the prevention of stroke and blood clots in patients with atrial fibrillation. It is the first replacement for warfarin to win FDA approval.
Because of successfully meeting efficacy criteria at a protocol-specified interim analysis, an independent data monitoring committee (IDMC) has recommended the early termination of Otsuka?s phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.
Giving cholesterol-lowering statin drugs to more people could be a cost-effective way of preventing heart attacks, US researchers said Sept. 27, as reported by Reuters. The study was published in Circulation.
For patients experiencing headache recurrence within 48 hours of an emergency department discharge, naproxen 500 mg or sumatriptan 100 mg taken orally relieves recurrent primary headache (including migraine, tension type, and cluster headaches) pain comparably, according to a report published in a recent issue of Annals of Emergency Medicine.
FDA has requested that all companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever, stop the manufacturing of this drug.
Treatment of rheumatoid arthritis (RA) with disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, biologics, or a combination of these agents significantly reduces radiographic evidence of joint destruction, with no advantage seen for patients whose treatment includes biologics, according to research published in the October issue of Arthritis & Rheumatism.
For women whose ovarian cancer has been in remission, restarting chemotherapy early on the basis of heightened CA125 concentration does not improve survival compared with postponing treatment until symptoms of relapse appear, according to a study published in the Oct. 2, cancer-themed issue of The Lancet.
Giving cholesterol-lowering statin drugs to more people could be a cost-effective way of preventing heart attacks, US researchers said Sept. 27, as reported by Reuters. The study was published in Circulation.
Ipilimumab (Bristol-Myers Squibb) intended to treat patients with stage III or IV metastatic melanoma has been granted priority review by FDA.
Individuals with ocular herpes simplex virus treated with prophylactic oral antibiotics appear to be at a lower risk of recurrence of epithelial keratitis, stromal keratitis, conjunctivitis, and blepharitis, according to research published in the September issue of the Archives of Ophthalmology, as reported by HealthDay News.
Two popular supplements used to treat joint pain don't work and health authorities should stop paying for them, according to a new study, as reported by HealthDay News
A method that is widely used to predict the risk of a major coronary event may over- or underestimate the risk for millions of Americans, according to a study directed by a researcher at the San Francisco VA Medical Center (SFVAMC) and the University of California, San Francisco (UCSF).
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