FDA approves new labelling for Seroquel in bioplar mania
...are, having recently overtaken olanzapine. The new label information is supported by data from two, 12-week, double-blind, randomised, placebo-controlled trials assessing the safety and efficacy of SEROQUEL monotherapy for the treatment of manic episodes in a large cohort of adults with bipolar I disorder....Intranasal corticosteroid receives FDA pregnancy Category B rating for allergic rhinitis
...c rhinitis." The FDA based its pregnancy category label change for RHINOCORT AQUA upon a review of data from three Swedish birth registries. These registries covered over 2,000 births from 1995-2001 (Swedish Medical Birth Registry, Registry of Congenital Malformations, and Child Cardiology Registry). The...New study demonstrates co-administration
...However, it is currently recommended in the TriCor label that TriCor be taken at least one hour before, or four to six hours after a BAS because of the potential for drug interactions. "Obviously the complexity of this dosing schedule can create difficulties for patients trying to comply with the tr...Researchers develop neural prosthesis allowing a monkey to feed self using only its brain
...hine by using each cell's preferred direction as a label and taking a continuous tally of the population throughout the intended movement. Monkeys were trained to reach for targets, and once the electrodes were in place, the algorithm was adjusted while the arms were restrained to assume the animal was int...FOSRENOL (R) maintains bone health status of end-stage renal disease patients
... patients treated with FOSRENOL in long-term, open label extensions. No effects of FOSRENOL on serum levels of 25-dihydroxy vitamin D3, vitamin A, vitamin B12,vitamin E and vitamin K were observed in patients who were monitored for 6 months. Paired bone biopsies (at baseline and at one or two years) in 69 ...ZETIA(R) co-administered with fenofibrate provided complementary lipid lowering efficacy
...rofile comparable to fenofibrate monotherapy. The label for ZETIA indicates that the safety and effectiven...IA and fenofibrate is not indicated for use in the label for ZETIA, however further studies in these populations are certainly warranted to confirm these fin...Reduced risk of institutionalisation in patients with dementia
...al trials of galantamine and their subsequent open label follow-up studies (3-4 years) 2,3,4. This data was supplemented with data collected retrospectively on former trial patients in 2004. All patients lived at home at entry into the clinical trials, and some of the patients in this study were observed f...Examination of possible conflicts of interest to influence look at suspected adverse drug reactions
...nterests of patients and industry, decisions about label changes, new studies, suspension of sales, or withdrawal of drugs might best be made by an outside group of disinterested reviewers." "In the United States, once a drug is approved for marketing, there is no regularly scheduled re-review of the drug....Researcher breaks down cholesterol mystery
...rt attacks. "We were the first in the world to label chylomicrons remnants with florescence and visually show that these particles can accumulate in arterial vessels," Proctor said. "Our next goal is to figure out why they get stuck and whether or not they play a significant role in the development of ...Repeated unexpected infant deaths most likely to be from natural causes
...d death is, in itself, insufficient to justify the label of infanticide. Although some families with an unexpected death have worryingly disorganised parenting skills and support structures, Carpenter and colleagues show that unexpected deaths recur, which implies that a diagnosis of infanticide should req...Grapefruit juice and medication can be a dangerous mix
... drug researchers, and that an appropriate warning label is included with each prescription. Nevertheless, ...ir patients every day: Read a medication's warning label carefully. If an interaction with grapefruit juice is possible, the patient should stop drinking the...Penn researchers add more evidence to demonstrate role of COX inhibitors in heart-disease risk
... this study are now incorporated in a revised drug label for Bextra available at the FDA website (www.fda.gov). This result is consistent with the original mechanism proposed by FitzGerald in 1999 that COX-2 inhibitors may be problematic for those at risk for heart disease. COX-2 is the main source of a fa...New test is first step in early detection of Alzheimer's disease
...ode DNA" because they have designed it as a unique label specific to the target. After the "particle-ADDL-particle" sandwich is removed magnetically from solution, the bar-code DNA is removed from the sandwich and read using standard DNA detection methodologies....US FDA grants full approval to DOXIL(R) following submission of phase III data
...99. As a result of the full approval, the product label for DOXIL has been updated to include survival, time to disease progression and tumor response rate data from a randomized Phase III clinical study. Under accelerated approval, DOXIL was indicated for the treatment of metastatic ovarian cancer in pa...