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

- May 5th, 2021

Bausch Health, Canada which is part of Bausch Health Companies Inc. today announced that Health Canada has approved the use of BRYHALI 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 …

 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

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

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