Filtered By:
Drug: Aspirin
Management: Food and Drug Administration (FDA)
This page shows you your search results in order of date.
Order by Relevance | Date
Total 25 results found since Jan 2013.
New VOYAGER PAD Analysis Confirms Consistent Benefit of XARELTO ® (rivaroxaban) Plus Aspirin Following Lower Extremity Revascularization (LER)
TITUSVILLE, NJ, March 5, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from a new prespecified analysis from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefits of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) over standard of care (aspirin alone), demonstrating consistent benefit at 30 days, 90 days and up to three years following LER in patients with PAD. Lower extremity revascularization, also called peripheral revascularization, is a procedure that restores blood flow in blocked arteries or veins. This analysis of ...
Source: Johnson and Johnson - March 5, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Data from New VOYAGER PAD Analyses at ACC.22 Reinforce Benefit of XARELTO ® (rivaroxaban) Plus Aspirin in Patients with Peripheral Artery Disease (PAD) and Various Co-Morbid Conditions
RARITAN, N.J., April 1, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with PAD after lower-extremity revascularization (LER), a procedure that restores blood flow to the legs. Data from the two analyses demonstrate the role that the XARELTO® vascular dose plays in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and ...
Source: Johnson and Johnson - April 1, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Can I use DOAC in a patient with renal disease?
Case
A 76-year-old man is diagnosed with non-valvular atrial fibrillation. His comorbid conditions are hypertension, diabetes complicated by neuropathy, and chronic kidney disease stage 3. His current medications include metformin, lisinopril, gabapentin, and aspirin. His most recent laboratories showed a creatinine 1.8, creatinine clearance (CrCl) 35 mL/min, hemoglobin 11g/dL, and international normalized ratio 1.0. His congestive heart failure, hypertension, age, diabetes, stroke, vascular disease, and sex (CHADSVASc) score is 4. Which medication should we use to prevent stroke in this patient?
Brief overview of the is...
Source: The Hospitalist - February 3, 2022 Category: Hospital Management Authors: Ronda Whitaker Tags: Renal & Genitourinary Source Type: research
FDA Approves Two New Indications for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, Dec. 20, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved two pediatric indications for XARELTO® (rivaroxaban): the treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of blood clots and blood-clot related events) in children aged two years and older with congenital heart disease who have...
Source: Johnson and Johnson - December 21, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.“We are committed to advancing the science and treatment of hematologic malignancies and look forward to presenting the latest research from our robust portfolio and pipeline during ASH...
Source: Johnson and Johnson - November 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
New Phase 3 Data Suggest Positive Effect and Show Similar Safety with XARELTO ® (rivaroxaban) Compared to Aspirin in Pediatric Fontan Procedure Patients at Risk for Blood Clots and Blood Clot-Related Events
RARITAN, NJ, September 27, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new data from the Phase 3 UNIVERSE study showing treatment with XARELTO® (rivaroxaban) in an oral suspension formulation, compared to treatment with aspirin, was associated with numerically fewer blood clots and clinical events strongly associated with blood clots in pediatric patients (aged 2-8 years) who have undergone the Fontan procedure. [1] These findings, which were published this month in the Journal of the American Heart Association and included in a recent New Drug Application submitted to the U.S. F...
Source: Johnson and Johnson - September 27, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO ® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD
RARITAN, N.J., August 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study. With this approval, XARELTO® is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) events in p...
Source: Johnson and Johnson - August 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
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 congenita...
Source: Johnson and Johnson - June 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
PCV22 Estimating the Reduction in Medical Care Costs Associated with Ticagrelor and Aspirin in Patients with Acute Ischemic Stroke or TIA
The efficacy of ticagrelor 90mg and aspirin (ticagrelor-aspirin) for the prevention of stroke following an ischaemic stroke (IS) or transient ischaemic attack (TIA) was evaluated in the Acute STroke or Transient IscHaemic Attack Treated With TicAgreLor and ASA for PrEvention of Stroke and Death (THALES, NCT03354429) trial. Ticagrelor-aspirin resulted in a 17% reduction in the risk of stroke or death over 30 days versus aspirin, but with more bleeding events. Ticagrelor 90mg is approved to reduce stroke risk in patients with acute IS (NIH Stroke Scale score ≤5) or high-risk TIA by the Food and Drug Administration.
Source: Value in Health - June 1, 2021 Category: International Medicine & Public Health Authors: P. McEwan, O. Darlington, M. Knutsson, H. Denison, P. Ladenvall, P. Amarenco, S.C. Johnston, S. Evans, S. James, A. Himmelmann, J. Venditto, C. Mellstrom, N. Atreja, A. Tank Source Type: research
Late-Breaking Data at ACC.21 Show XARELTO ® (rivaroxaban) Plus Aspirin Significantly Reduced Total Ischemic Events in Peripheral Artery Disease (PAD) Patients After Lower-Extremity Revascularization
RARITAN, N.J., May 16, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today presented new data from the Phase 3 VOYAGER PAD study which showed XARELTO® (rivaroxaban) (2.5 mg twice daily) in combination with aspirin (100 mg once daily) consistently reduced severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER) compared to aspirin alone regardless of whether it was the first, second, third, or subsequent event. The primary results of VOYAGER PAD showed that XARELTO® plus aspirin reduced first events by 15 percent among patients with PAD ...
Source: Johnson and Johnson - May 16, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revascularization, a c...
Source: Johnson and Johnson - October 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
FDA Approves New Drug For Migraine Sufferers
(CNN) — The US Food and Drug Administration on Monday announced the approval of a drug called ubrogepant for the acute treatment of migraine, which could be a new option for people who can’t take or don’t respond to migraine medications currently on the market.
The drug will be sold under the name Ubrelvy by the pharmaceutical company Allergan. It is considered effective for migraine with or without aura, referring to the sensory or visual disturbances that occur among roughly a third of migraine sufferers.
“Ubrelvy represents an important new option for the acute treatment of migraine in adults, as...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - December 24, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Syndicated CBSN Boston FDA Migraines Source Type: news
New Drug To Treat Migraines Shows Promise
(CNN) — A new drug to treat migraines has shown promise in a large-scale clinical trial, offering hope to people unable to use current treatment options.
The drug, ubrogepant, showed greater rates of pain and symptom relief from migraine compared to a placebo, with more than 20% of participants given the drug reporting to be pain-free within two hours and more than 34% relieved of the most bothersome symptoms linked to migraine, which include light and noise sensitivity. This is compared to 14% and 27%, respectively, from the placebo.
“Having ubrogepant as a potential new medication for the acute treatment of m...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - November 19, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News CNN Migraines Source Type: news
Aspirin Lowers Your Chances of a Heart Attack. But It ’s Not Safe for Everyone, a New Study Says
As medications go, aspirin is often considered a wonder drug. Its pain-relieving, inflammation-taming powers can treat headaches, minor aches and pains and even lower the risk of heart disease, stroke and possibly even dementia.
But all of those benefits may come at a price, according to the latest study to analyze aspirin’s risks and benefits, especially for people who take the drug as a way to prevent having a first heart event. In a study published in JAMA, researchers led by Dr. Sean Zheng at King’s College London found that the risks of aspirin — primarily of bleeding in the stomach and intestinal tr...
Source: TIME: Health - January 23, 2019 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized healthytime Heart Disease Source Type: news
Aspirin Lowers Your Chances of a Heart Attack. But It ’s Not Safe for Everyone
As medications go, aspirin is often considered a wonder drug. Its pain-reliving, inflammation-taming powers can treat headaches, minor aches and pains and even lower the risk of heart disease, stroke and possibly even dementia.
But all of those benefits may come at a price, according to the latest study to analyze aspirin’s risks and benefits, especially for people who take the drug as a way to prevent having a first heart event. In a study published in JAMA, researchers led by Dr. Sean Zheng at King’s College London found that the risks of aspirin — primarily of bleeding in the stomach and intestinal tra...
Source: TIME: Health - January 23, 2019 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized healthytime Heart Disease Source Type: news
