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Drug: New Drug Applications
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Total 14 results found since Jan 2013.
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
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
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
New XARELTO ® (rivaroxaban) Peripheral Artery Disease (PAD) Data from EXPLORER Clinical Research Program to be Unveiled at American Heart Association (AHA) Scientific Sessions 2020
RARITAN, N.J., November 9, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that 10 data presentations will be shared at the virtual American Heart Association (AHA) Scientific Sessions 2020 from November 13-17. Most notably, four new sub-analyses of XARELTO® (rivaroxaban) from the landmark VOYAGER PAD trial, part of the EXPLORER global cardiovascular research program, will be presented, including two live, featured science oral presentations. “We're pleased VOYAGER PAD was selected to be front and center once again at a major medical congress, as there's an urgent need for data in ...
Source: Johnson and Johnson - November 9, 2020 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
Johnson & Johnson Reports 2020 Third-Quarter Results
New Brunswick, N.J. (October 13, 2020) – Johnson & Johnson (NYSE: JNJ) today announced results for third-quarter 2020. “Our third-quarter results reflect solid performance and positive trends across Johnson & Johnson, powered by better-than-expected procedure recovery in Medical Devices, growth in Consumer Health, and continued strength in Pharmaceuticals,” said Alex Gorsky, Chairman and Chief Executive Officer. “I am proud of the relentless passion and Credo-led commitment to patients and customers that our colleagues around the world continue to demonstrate as we boldly fight the COVID-19 pandemic. Our wo...
Source: Johnson and Johnson - October 13, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news
Cardiovascular Safety of Prucalopride in Patients with Chronic Constipation: A Multinational Population-Based Cohort Study
ConclusionsThe pooled incidence rate ratio estimate was consistent with no indication of an increased risk above the pre-specified safety threshold of 3.00 for major adverse cardiovascular events in patients with chronic constipation using prucalopride as compared with PEG.
Source: Drug Safety - May 26, 2019 Category: Drugs & Pharmacology Source Type: research
In Brief: Tegaserod (Zelnorm) Returns
Date: May 6, 2019
Issue #:
1571Summary:
Tegaserod maleate(Zelnorm), a 5-HT4 receptor partial agonist that increases gastrointestinal (GI) motility, was approved by the FDA in 2002 for short-term treatment of irritable bowel syndrome with constipation (IBS-C) in women and in 2004 for treatment of chronic idiopathic constipation (CIC) in adults<65 years old.In 2007, the manufacturer (Novartis) complied with an FDA request to stop marketing the drug based on an unpublished retrospective analysis of clinical trials in IBS-C and other GI motility disorders that showed a higher rate of ischemic ...
Source: The Medical Letter - April 26, 2019 Category: Drugs & Pharmacology Authors: admin Tags: Constipation irritable bowel syndrome Motegrity prucalopride Resotran Tegaserod Zelnorm Source Type: research
Janssen Submits Supplemental New Drug Application (sNDA) to U.S. FDA Seeking New Indication for INVOKANA ® (canagliflozin) to Reduce the Risk of Major Adverse Cardiovascular Events (MACE) Based on Landmark CANVAS Program
Filing includes data on the combined risk reduction of cardiovascular death, myocardial infarction and stroke in patients with type 2 diabetes
Source: Johnson and Johnson - October 2, 2017 Category: Pharmaceuticals Source Type: news
MassDevice.com +5 | The top 5 medtech stories for March 8, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Court clears Caldera’s $12.3m transvaginal mesh settlement
A California federal judge last week approved a $12.3 million deal to settle a number of insurance claims over injuries allegedly caused by Caldera Medical’s transv...
Source: Mass Device - March 8, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Merck Receives Complete Response Letter from the U.S. FDA for ZETIA® (ezetimibe) and VYTORIN® (ezetimibe and simvastatin)
Dateline City:
KENILWORTH, N.J.
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
announced today that the U.S. Food and Drug Administration (FDA) has
issued a Complete Response Letter regarding Merck's Supplemental New
Drug Applications for ZETIA® and VYTORIN® for the reduction of the risk
of cardiovascular events (cardiovascular death, nonfatal myocardial
infarction, nonfatal stroke, hospitalization for unstable angina, or
need for revascularization) in patients with coronary heart disease.
Language:
...
Source: Merck.com - Product News - February 15, 2016 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News Source Type: news
Merck Receives Complete Response Letter from the U.S. FDA for ZETIA ® (ezetimibe) and VYTORIN® (ezetimibe and simvastatin)
Dateline City:
KENILWORTH, N.J. KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
announced today that the U.S. Food and Drug Administration (FDA) has
issued a Complete Response Letter regarding Merck ' s Supplemental New
Drug Applications for ZETIA ® and VYTORIN® for the reduction of the risk
of cardiovascular events (cardiovascular death, nonfatal myocardial
infarction, nonfatal stroke, hospitalization for unstable angina, or
need for revascularization) in patients with coronary heart disease. Language:
English ...
Source: Merck.com - Product News - February 15, 2016 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News Source Type: news
FDA Once Again Rejects New Indication For Johnson & Johnson's Xarelto
The third time wasn't the charm. The FDA today turned turned down-- for the third time-- the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke or death. In addition, the FDA-- for the second time-- turned down the sNDA for rivaroxaban in the same population for the reduction of stent thrombosis.
Source: Forbes.com Healthcare News - February 14, 2014 Category: Pharmaceuticals Authors: Larry Husten Source Type: news
Merck Announces FDA Acceptance of New Drug Application for Vorapaxar, Investigational Anti-Thrombotic Medicine
Dateline City:
WHITEHOUSE STATION, N.J.
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the New Drug Application (NDA) for its
investigational anti-thrombotic medicine, vorapaxar, has been accepted
for standard review by the U.S. Food and Drug Administration (FDA).
Merck is seeking FDA approval of vorapaxar for the secondary prevention
of cardiovascular events in patients with a history of heart attack and
no history of stroke or transient ischemic attack (TIA).
About Mer...
Source: Merck.com - Research and Development News - July 24, 2013 Category: Pharmaceuticals Authors: hq_site_admin Tags: Research and Development News Corporate News Latest News Source Type: news
