Fixed-Dose Macitentan/Tadalafil Combo Gets FDA Approval for PAH
(MedPage Today) -- FDA approved macitentan/tadalafil (Opsynvi) as the first single-tablet combination therapy targeting multiple pathways for pulmonary arterial hypertension (PAH), Johnson & Johnson announced.
The fixed-dose combination of... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - March 25, 2024 Category: American Health Source Type: news
U.S. FDA Approves OPSYNVI ® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH)
OPSYNVI® combines two proven treatments with established efficacy and safety profiles into one tablet to be taken once daily, offering an option that helps to support the implementation of clinical guideline recommendations for early use of combination therapy.1 The comprehensive PAH... (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - March 22, 2024 Category: Pharmaceuticals Tags: FDA Source Type: news
FDA Approves Opsynvi (macitentan and tadalafil) for Adults with Pulmonary Arterial Hypertension
RARITAN, NJ, March 22, 2024– Johnson& Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi®– a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 22, 2024 Category: Drugs & Pharmacology Source Type: news
Pyramid Wholesale Issues Recall of Various Brands of Products Sold as Dietary Supplements for Sexual Enhancement Because They Contain Undeclared Prescription Drugs Including Sildenafil (Viagra) and/or Tadalafil (Cialis)
Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 20, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Revealed: Erection pills such as Viagra and Cialis have been linked to over 200 deaths in Britain
None of the fatalities - all of which have occurred since 1998 - are proven to have been caused directly by the drugs but come from reports summitted by concerned patients and medics. (Source: the Mail online | Health)
Source: the Mail online | Health - March 18, 2024 Category: Consumer Health News Source Type: news
Man breaks out in pustules in never-before-seen reaction to £5 erectile dysfunction drug sold on high street
The 40-year-old developed pustules - small bumps on the skin containing fluid or pus - covering his chest, face and thighs after taking tadalafil, sold as Cialis in the UK. (Source: the Mail online | Health)
Source: the Mail online | Health - February 9, 2024 Category: Consumer Health News Source Type: news
Viagra, Cialis May Help Reduce Alzheimer's Risk
THURSDAY, Feb. 8, 2023 -- Could drugs that give a boost to men ' s sexual performance help them stave off Alzheimer ' s disease?
That ' s the main finding from a study suggesting that erectile dysfunction meds like Cialis, Levitra and Viagra might lower... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - February 8, 2024 Category: General Medicine Source Type: news
More Data Show ED Meds May Affect Alzheimer's Risk More Data Show ED Meds May Affect Alzheimer's Risk
Men with newly diagnosed erectile dysfunction who were prescribed drugs like sildenafil or tadalafil were 18% less likely to develop AD at 5-years follow-up, new research shows.Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - February 7, 2024 Category: Endocrinology Tags: Neurology & Neurosurgery Source Type: news
Today The World Issues Voluntary Nationwide Recall of All Lots of Sustain and Schwinnng brand Dietary Supplement Capsules Due to the Presence of Undeclared Tadalafil and Nortadalafil
“Today The World” is voluntarily recalling two lots of Sustain herbal dietary supplement capsules and one lot of Schwinnng capsules to the consumer level. FDA analysis has found the products to contain undeclared Tadalafil and Nortadalafil (structurally similar to Tadalafil). Tadalafil and Norta dala (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Today The World Issues Voluntary Nationwide Recall of All Lots of Arize Herbal Dietary Supplement Capsules Due to the Presence of Undeclared Nortadalafil
“Today The World” is voluntarily recalling one lot of Arize Herbal Dietary Supplement capsules to the consumer level.
FDA analysis has found the products to contain undeclared Nortadalafil (structurally similar to Tadalafil). Nortadalafil is an active drug ingredient known for treatment of male ere (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Viagra, Cialis Plus a Heart Med Could Be a Dangerous Combo
MONDAY, Jan. 15, 2024 -- Taking nitrates for heart problems alongside erectile dysfunction drugs like Viagra or Cialis could be a prescription for trouble, a new study warns.
Men who combine the two types of medications have a higher risk of death... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - January 15, 2024 Category: General Medicine Source Type: news
5 Common Myths About Erectile Dysfunction
There’s a lot of misinformation about erectile dysfunction — a recurring inability to get an erection or sustain one during sex. Bad information, though, could lead men to wrongly assume that it’s a condition they must live with or that it requires expensive treatment. Here are 5 common myths…#myth2 #hims #himscom #learn #viagra #cialis (Source: Reuters: Health)
Source: Reuters: Health - October 24, 2023 Category: Consumer Health News Source Type: news
Forget Viagra! Men can now get another erection drug without needing a prescription
Boots is now selling Cialis without the need for a prescription. It follows a rule change earlier this year to reclassify the impotence drug, in a move hailed as 'good news for men's health'. (Source: the Mail online | Health)
Source: the Mail online | Health - June 6, 2023 Category: Consumer Health News Source Type: news
Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
This is the first and only single tablet combination therapy application to be submitted for review in the U.S. for this rare, progressive disease
If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 30, 2023 Category: Drugs & Pharmacology Source Type: news
Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
RARITAN, NJ, May 30, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of an investigational single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients with WHO functional class (FC) II-III.[1] The application is based on positive data from the Phase 3 A DUE study, which met its primary endpoint and demonstrated that M/T STCT si...
Source: Johnson and Johnson - May 30, 2023 Category: Pharmaceuticals Source Type: news
