Janssen Submits New Drug Application to U.S. FDA for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients

RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO® (rivaroxaban) in pediatric patients. The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure. If approved, XARELTO® will be the first and only oral Factor Xa inhibitor indicated in the U.S. for use in pediatric patients.CLICK TO TWEET: @JanssenUS announces NDA submission to @US_FDA for two new potential pediatric indications for the treatment and prevention of #bloodclots. Learn more: https://ctt.ac/dS3qz+Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurring blood clots with standard anticoagulant therapy, which often requires painful injections, dietary restrictions and regular laboratory monitoring. There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure, a surgical procedure that redirects blood flow from the lower body to the lungs. ...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

Related Links:

Source: BMJ Comments - Category: General Medicine Source Type: forums
Discussion The hands are one of the most important parts of the body for interacting with the world. They are remarkably adapted having sensitive sensory receptors as well as feedback receptors for grasping, holding, and manipulating objects. Hands, especially with an opposable thumb, multiple joints within the hand, along with the wrist and elbow, allow the hand to move in multiple positions to manipulate the world. Hands also symbolize an emotional caring and sharing between individuals as hands are used to provide a true “human touch” in personal and social situations. Due to their important interactions in ...
Source: PediatricEducation.org - Category: Pediatrics Authors: Tags: Uncategorized Source Type: news
Prof Dame Sarah Gilbert says this will not be the last time a virus threatens our lives and our livelihoodsCoronavirus – latest updatesSee all our coronavirus coverageThe coronavirus pandemic that has so far killed more than 5 million people worldwide is far from over and the next one could be even more lethal, the creator of the Oxford/AstraZeneca vaccine has said.As fears grow over the threat posed by the highly mutated Omicron variant, detected in more than 30 countries,Prof Dame Sarah Gilbert cautioned that while it was increasingly obvious that “this pandemic is not done with us”, the next one could ...
Source: Guardian Unlimited Science - Category: Science Authors: Tags: Coronavirus UK news World news Science Infectious diseases Source Type: news
lzania Marialuisa Zedde Patent Foramen Ovale (PFO) is a common postnatal defect of cardiac atrial septation. A certain degree of familial aggregation has been reported. Animal studies suggest the involvement of the Notch pathway and other cardiac transcription factors (GATA4, TBX20, NKX2-5) in Foramen Ovale closure. This review evaluates the contribution of genetic alterations in PFO development. We systematically reviewed studies that assessed rare and common variants in subjects with PFO. The protocol was registered with PROSPERO and followed MOOSE guidelines. We systematically searched English studies reporting ra...
Source: Genes - Category: Genetics & Stem Cells Authors: Tags: Review Source Type: research
An Italian healthcare worker was caught trying to fraudulently receive a Covid-19 vaccine in a silicone arm.
Source: Forbes.com Healthcare News - Category: Pharmaceuticals Authors: Tags: Healthcare /healthcare Innovation /innovation Source Type: news
A small study in Boston looked at mixing and matching with the third shot.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Vaccination and Immunization Coronavirus (2019-nCoV) Johnson & Pfizer Inc BioNTech SE Source Type: news
NEW BRUNSWICK, N.J., DECEMBER 5, 2021 – Johnson &Johnson (NYSE: JNJ) (the Company) today announced preliminary results from an independent study, including a subset of participants from the Janssen-sponsored COV2008 study, conducted by Dan Barouch, M.D., Ph.D., et al. of Beth Israel Deaconess Medical Center (BIDMC), which showed that a booster shot of the Johnson &Johnson COVID-19 vaccine (Ad26.COV2.S), administered at six months after a two-dose primary regimen of BNT162b2, increased both antibody and T-cell responses. These results demonstrate the potential benefits of heterologous boosting (mix-and-match)....
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
A STROKE is a medical emergency and urgent treatment is essential. There are fortunately several ways to reduce your risk.
Source: Daily Express - Health - Category: Consumer Health News Source Type: news
Experts said it is likely that there is already community spread of the variant in the United States.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Coronavirus Omicron Variant Coronavirus (2019-nCoV) Vaccination and Immunization Collins, Francis S Fauci, Anthony S Van Kerkhove, Maria Walensky, Rochelle United States South Africa Disease Rates Source Type: news
In my last post I described the “4 P” model (sometimes called the 5P!) of formulation for pain. In today’s post I want to talk about an integrated approach for a team. Teamwork in pain management is an enormous thing – IASP (International Association for the Study of Pain) endorses multidisciplinary (I prefer interprofessional) teamwork but gives little information on how teams best work together. In fact, research exploring teamwork processes in pain management is remarkably absent, even though there’s considerable research elsewhere in healthcare showing that effective teamwork is quite ...
Source: HealthSkills Weblog - Category: Anesthesiology Authors: Tags: Assessment Chronic pain Clinical reasoning Interdisciplinary teams Professional topics Psychology Research Science in practice biopsychosocial case formulation Health healthcare pain management teamskills teamwork Source Type: blogs
More News: Allergy & Immunology | Anesthesia | Anesthesiology | Antiphospholipid Syndrome | Aspirin | Atrial Fibrillation | Babies | Babies Heart Conditions | Back Pain | Bleeding | Brain | Breastfed | Canada Health | Cancer & Oncology | Cardiology | Cardiovascular | Cardiovascular & Thoracic Surgery | Child Development | Children | Chronic Pain | Clinical Trials | Clopidogrel | Complementary Medicine | Cough | Coumadin | Dentistry | Diabetes | Diabetes Type 2 | Diets | Emergency Medicine | Endocrinology | Epistaxis (Nosebleeds) | Food and Drug Administration (FDA) | Headache | Health Management | Heart | Heart Attack | Heart Disease | Heart Transplant | Heart Valve Disease | Heart Valve Surgery | Heart Valves | Herbs | Hospitals | Hughes Syndrome | Hypertension | Incontinence | Infectious Diseases | Japan Health | Kidney Transplant | Laboratory Medicine | Learning | Legislation | Liver | Liver Transplant | Lung Transplant | Men | Milk | Neurology | Neuroscience | Neurosurgery | New Drug Applications | Nutrition | Pain | Pediatrics | Peripheral Vascular Disease (PVD) | Pharmaceuticals | Physiology | Plavix | Pregnancy | Profits and Losses | Pulmonary Hypertension | Pulmonary Thromboembolism | Science | Sodium | Stroke | Study | Switzerland Health | Thrombosis | Universities & Medical Training | Urology & Nephrology | Vaccines | Vitamin A | Vitamins | Warfarin | Warnings