Health Canada Issues Notice of Compliance for Bausch Health's BRYHALI

 Bausch Health, Canada which is part of Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), ("Bausch Health" or the "Company") today announced that Health Canada has approved the use of BRYHALI (Halobetasol Propionate Lotion 0.01% ww), a high to super-high potency topical corticosteroid indicated for Corticosteroid-Responsive Dermatoses and the topical treatment of plaque psoriasis.i Some of the most "commonly-encountered skin disorders under the Corticosteroid-Responsive Dermatoses umbrella include seborrheic dermatitis and eczematous dermatoses such as atopic dermatitis and contact dermatitis." ii

Bausch Health logo (CNW Group/Bausch Health)

BRYHALI lotion is formulated with PRISMATREX™  technology, a novel polymeric emulsification system, which provides a stable condition where emulsion droplets retain their distribution across time and temperature. iii BRYHALI is applied once daily and can be used for up to eight weeks.

"With Health Canada's approval of BRYHALI, patients suffering from corticosteroid-responsive dermatoses and will soon have an innovative topical treatment option with the active ingredient halobetasol propionate, a corticosteroid designed to help reduce inflammation," said Ginette Gagné, Interim President and General Manager, Bausch Health , Canada . "BRYHALI is a welcome addition to our dermatology portfolio, which is comprised of the largest number of innovative dermatology products in Canada , and we remain committed to bringing forward new medicines to help improve the lives of Canadians."

"Topical corticosteroids are commonly used for many corticosteroid-responsive dermatoses – they are known to offer relief from itching and inflammation," said Dr. Shear, dermatologist, professor emeritus, University of Toronto . "BRYHALI lotion is a welcome new addition, offering a lotion that is formulated with the PRISMATREX™  technology system."

BRYHALI will be available in Canada in the coming months.

BRYHALI is manufactured at the Company's Laval, Quebec manufacturing facility for both Canadian and U.S. patients.

About Bausch Health Companies Inc.
Bausch Health Companies Inc. (NYSE/TSX: BHC ) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health.

In Canada, the Company's prescription product portfolio is focused on eye health, dermatology, and cardio-metabolic conditions. More information can be found on the Company's website at bauschhealth.ca .

References



i.

PM BRYHALI, April 13, 2021

ii.

Kircik LH, Del Rosso JQ. The treatment of inflammatory facial dermatoses with topical corticosteroids: focus on clocortolone pivalate 0.1% cream. J Drugs Dermatol. 2012 Oct;11(10):1194-8. PMID: 23134984.

iii.

Data in Health Canada NDS submission

SOURCE Bausch Health

Cision View original content to download multimedia: https://www.newswire.ca/en/releases/archive/May2021/05/c3468.html

News Provided by Canada Newswire via QuoteMedia

The Conversation (0)

Healing People and Planet: New Impact Report Outlines How Medtronic Is Shaping the Future of Health

Medtronic

Medtronic releases 2024 Impact Report highlighting success in healthcare equity with new data from the Healthy Neighbor program, in addition to community engagement and environmental sustainability progress

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Artificial Intelligence Reshaping Healthcare Industry with Unimaginable Potential

FN Media Group News Commentary - The Healthcare Artificial Intelligence (AI) market exhibits a high degree of innovation, characterized by ongoing advancements in technology. Rapid developments in ML, deep learning, NLP, and computer vision are driving the evolution of AI-powered healthcare solutions. One primary factor driving market growth is the increasing demand in the healthcare sector for enhanced efficiency, accuracy, and better patient outcomes. According to a March 2024 Microsoft-IDC study, 79% of healthcare organizations are presently utilizing AI technology. In addition, the return on investment (ROI) is realized within 14 months, generating USD 3.20 for every USD 1 invested in artificial intelligence (AI). AI technologies hold transformative potential in various areas including medical imaging analysis, predictive analytics, personalized treatment planning, and drug discovery, potentially transforming conventional healthcare practices. A report from Grand View Research said the global AI in healthcare market size, which was estimated at USD 19.27 billion in 2023, is expected to grow at a CAGR of 38.5% from 2024 to 2030. The report said: "Mergers & acquisitions (M&As) play a significant role in shaping the healthcare AI market landscape. Companies [that] engage in M&A activities to expand their AI software and services increase their market reach or acquire specialized technology and expertise. End-users are becoming increasingly aware of the potential benefits of AI in improving patient care, operational efficiency, and healthcare outcomes. Education initiatives and industry events helped raise awareness about the capabilities and applications of AI in healthcare." A.I. companies active in the markets include: Avant Technologies Inc. (OTCQB: AVAI), Teladoc Health, Inc. (NYSE: TDOC), Tempus AI, Inc. (NASDAQ: TEM), Medtronic plc (NYSE: MDT), Clover Health Investments, Corp. (NASDAQ: CLOV).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Medtronic receives FDA clearance for new InPen app, paving the way for its Smart MDI system launch with Simplera CGM

New Smart MDI system will be the first system to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses.

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) clearance for its new InPen™ app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera™ continuous glucose monitor (CGM). The company's Smart MDI system combines its InPen™ smart insulin pen with its newest Simplera™ CGM — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Medtronic reports second quarter fiscal 2025 financial results

Delivering on commitments, executing ahead of expectations, and raising guidance

Innovation driving sustained growth across many franchises:  TAVR, PFA, Leadless Pacemakers, Diabetes, Spine, and Neuromodulation

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Knight Therapeutics Announces Health Canada Approval for JORNAY PM to Treat Attention-Deficit Hyperactivity Disorder

Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved JORNAY PM â„¢, an extended-release formulation of methylphenidate, a stimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children.

JORNAY PM â„¢ is the first and only evening-dosed methylphenidate product commercially available in Canada to treat ADHD in patients from 6 to 12 years of age. JORNAY PM â„¢ consists of microbeads with a delayed-release layer and an extended-release layer. The first layer delays the release of the active ingredient until morning while the extended-release layer controls the release of the active ingredient starting in the morning and continuing throughout the day. This unique formulation provides a pharmacokinetic profile that allows ADHD symptom control from the time patients wake up until the evening.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Mainz Biomed and Thermo Fisher Scientific Sign a Collaboration Agreement for the Development of Next Generation Colorectal Cancer Screening Product for Global Markets

Mainz Biomed N.V. (NASDAQ:MYNZ) ("Mainz Biomed" or the "Company"), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced a collaborative agreement with Thermo Fisher Scientific Inc. (NYSE: TMO), through its subsidiary Life Technologies Corporation ("Thermo Fisher"), a world leader in supplying life sciences solutions and services.

The collaboration agreement will enable Mainz Biomed and Thermo Fisher to jointly develop and potentially commercialize Mainz Biomed's Next Generation colorectal cancer screening product. The collaboration will harness Thermo Fisher's powerful technologies, instrumentation and information translation systems to enable Mainz Biomed to develop the proprietary assays for its mRNA-based next-generation CRC screening tests which are redefining standards in early cancer detection. Mainz Biomed's flagship non-invasive test not only targets the early detection of colorectal cancer but also focuses on precancerous lesions, particularly advanced adenomas, demonstrating significant clinical success in both US and European trials.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×