Medication Update. FDA approves new antidepressant.doi:10.1097/01.NPR.0000394874.67620.faEBSCO_AspNurse Practitioner
The US FDA approved aducanumab in June 2021 on the basis of the data of the EMERGE and ENGAGE trials. Both trials presented evidence of an intermediate effect of the drug on biomarkers, indicating amyloid removal, which is likely linked to the clinical benefit of aducanumab. Further trials ...
Travivo (Gepirone ER) is an antidepressant medication that was initially rejected multiple times by the FDA due to concerns of efficacy. It was first rejected in 2004, then again in 2007. That said, the FDA reviewed data for Gepirone in 2015 and reversed their initial rejection of the drug...
Otsuka Pharmaceutical, Co. Ltd. and Lundbeck LLC announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of REXULTI® (brexpiprazole) for use in the treatment of agitation associated with dementia
In essence, will this medication be an advance, and when and for whom should I prescribe it? These questions are particularly relevant for the treatment of depression because many antidepressant agents targeting monoamine receptors are already available, many of which are generic. Despite the already...
FDA and ABCs: Unintended Consequences of Antidepressant Warnings on Academic Achievement In 2003 and 2004 the FDA issued a series of warnings noting a possible association between pediatric antidepressant use and suicidality. The FDA D Bloome 被引量: 1发表: 2015年 ...
35 No. 8 NEW DRUGS Dulera for Asthma Merck has announced the FDA's ap proval of mometasone furoate/formo terol fumarate dihydrate (Dulera), a respiratory drug for asthma in patients 12 years of age and older; however, a boxed warning states that this agent can increase the risk of death...
decline, which was similar to that observed among the participants in the EMERGE trial. The US FDA approved aducanumab in June 2021 on the basis of the data of the EMERGE and ENGAGE trials. Both trials presented evidence of an intermediate effect of the drug on biomarkers, indicating amyloid ...
On Sept. 26, the FDA approved the first truly new antipsychotic in decades:Cobenfy. In clinical trials, it didn’t cause certain side effects that traditionally interfere with medication adherence, including weight gain, lethargy, and movement disorders. ...
Supernus Pharma received an NDA for a new molecule, Viloxazine. This is the first novel non-stimulant medication to treat ADHD in children. Viloxazine was marketed for more than two decades as an antidepressant in Europe. Relapsed or refractory (R/R) B-cell acute lympho...