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Psoriasis Treatment Receives Tentative FDA Approval

Bausch Heath news release; 2018 Oct 8

Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, has announced that the US Food and Drug Administration (FDA) has provided tentative approval of the New Drug Application for Bryhali (halobetasol propionate) Lotion, 0.01%, for the topical treatment of plaque psoriasis in adult patients. The final FDA approval for Bryhali Lotion is pending the expiration of exclusivity for a related product, which is expected in early November 2018. Bausch Health Companies Inc. is headquartered in Laval, Quebec, Canada.

Indications: Bryhali Lotion is a new potent to super-potent corticosteroid that contains 0.01% halobetasol propionate in a novel vehicle lotion. Its safety has been established in clinical trials with dosing for up to 8 weeks with no increase in epidermal atrophy.

Adverse reactions: The most common adverse reactions occurring in ≥1% of subjects treated with Bryhali Lotion through week 8 were upper respiratory tract infection (2%), application site dermatitis (1%), and hyperglycemia (1%).


Bausch Health's Bryhali (halobetasol propionate) Lotion, 0.01%, receives tentative FDA approval for plaque psoriasis in adults. Laval, Quebec, Canada: Bausch Health Companies Inc., Ortho Dermatologics. October 8, 2018. Accessed October 8, 2018.

This Week's Must Reads

Psoriasis Linked with Increased All-Cause Mortality, J Am Acad Dermatol; ePub 2018 Dec 24; Dhana, et al

Examining Patient Resistance to Psoriasis Treatment, Exp Opin Pharmacother; ePub 2018 Dec 27; Heath, et al

Psoriasis Linked with Periodontal Inflammation, J Invest Dermatol; ePub 2019 Jan 2; Woeste, et al

Psoriasis Independently Linked with Depression Risk, Br J Dermatol; 2019 Jan; Egeberg, Thyssen, Wu, et al

Health Literacy May Benefit Patients with Psoriasis, Br J Dermatol; ePub 2018 Dec 31; Larsen, et al

Must Reads in FDA Actions

FDA Approves Hyrimoz for Plaque Psoriasis, Sandoz news release; 2018 Oct 31

FDA Approves Seysara for Severe Acne Vulgaris, Paratek Pharmaceuticals, Inc. news release; 2018 Oct 2

FDA Approves Nuzyra for Acute Skin Infections, Paratek Pharmaceuticals, Inc. news release; 2018 Oct 2

Psoriasis Treatment Receives Tentative FDA Approval, Bausch Heath news release; 2018 Oct 8

FDA Approves Libtayo for Metastatic cSCC, Sanofi news release; 2018 Sep 28