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April 25, 2019
ORTHO DERMATOLOGICS RECEIVES FDA APPROVAL OF DUOBRII™ (HALOBETASOL PROPIONATE AND TAZAROTENE) LOTION 0.01%/0.045% FOR PLAQUE PSORIASIS IN ADULTS

First and Only Topical Lotion Combining Halobetasol Propionate and Tazarotene in One Formulation1

Safety was Established in a Long-Term Study of Up to 24 Weeks of Continuous Use and up to 52 Weeks of As-Needed Use2

RALEIGH, N.C., Apr. 25, 2019 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses in the world, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for DUOBRII™ (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, indicated for the topical treatment of plaque psoriasis in adults.1 DUOBRII is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation. In a year-long safety study, patients used DUOBRII Lotion for up to 24 weeks of continuous use and up to 52 weeks of as-needed use.2 DUOBRII is expected to be available in June 2019.

1. DUOBRII™ [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC.
2. Lebwohl, M.G. et al. Long-term safety results from a phase 3 open-label study of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate-to-severe plaque psoriasis. Journal of Americal Academy of Dermatology. 2019 Jan;80(1):282-285.

March 11, 2019
ORTHO DERMATOLOGICS LAUNCHES 2019 ASPIRE HIGHER SCHOLARSHIP PROGRAM FOR STUDENTS WITH DERMATOLOGIC CONDITIONS

Students Can Apply for the Scholarship Through April 26, 2019

RALEIGH, N.C., March 11, 2019 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the opening of applications for its 2019 Aspire Higher scholarship program, which will award $90,000 total in scholarships to nine students who have been treated for a dermatologic condition.

February 28, 2019
ORTHO DERMATOLOGICS TO PRESENT NEW ANALYSES AT THE AMERICAN ACADEMY OF DERMATOLOGY ANNUAL MEETING

10 Poster Presentations Include New Analyses of Phase 3 Data on Investigational Drug DUOBRII™ 1 and SILIQ™

RALEIGH, N.C., Feb. 28, 2019 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the presentation of 10 posters during the American Academy of Dermatology Annual Meeting in Washington, D.C., March 1-5, 2019.

February 27, 2019
ORTHO DERMATOLOGICS LAUNCHES FIRST CASH-PAY PRESCRIPTION PROGRAM IN DERMATOLOGY

Program Will Increase Patient Access to High Quality Dermatology Brands for Certain Conditions That Typically Face Insurance Challenges and High Prescription Costs
No Insurance, Copays, or Prior Authorizations Needed

RALEIGH, N.C., Feb. 27, 2019 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, announced today the launch of an innovative cash-pay prescription program that will make many branded products available directly to patients with a valid prescription only – no insurance, co-pays or prior authorizations needed. The program is specifically designed to provide physicians and patients with direct access to a range of proven treatment options for certain disease states that typically encounter insurance coverage hassles and high prescription costs including acne, actinic keratosis (AK), superficial basal cell carcinoma (sBCCs), barrier repair (e.g. eczema treatments), wounds and corticosteroid-responsive diseases (CRDs) like rashes, psoriasis, and atopic dermatitis (AD).

November 7, 2018
ORTHO DERMATOLOGICS ANNOUNCES U.S. LAUNCH OF BRYHALI™ (HALOBETASOL PROPIONATE) LOTION, 0.01%, FOR PLAQUE PSORIASIS IN ADULTS

Launch Expected to Occur Later this Month Following Final FDA Approval

RALEIGH, N.C., Nov. 7, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced it expects to start distribution of BRYHALI™ (halobetsasol propionate) Lotion, 0.01%, to U.S. wholesale pharmaceutical distributors later this month. The company received final approval from the U.S. Food and Drug Administration (FDA) for BRYHALI Lotion on Nov. 6, 2018. BRYHALI Lotion, which is indicated for the topical treatment of plaque psoriasis in adult patients, is a new potent to superpotent corticosteroid in a novel vehicle lotion with safety established for dosing up to eight weeks.1

1. BRYHALI™ [prescribing information]. Bridgewater, NJ: Ortho Dermatologics.

October 30, 2018
ORTHO DERMATOLOGICS LAUNCHES ALTRENO™ (TRETINOIN) LOTION, 0.05% IN THE UNITED STATES

RALEIGH, N.C., Oct. 30, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the U.S. launch of ALTRENO™ (tretinoin) Lotion, 0.05% for the topical treatment of acne vulgaris in patients 9 years of age and older. ALTRENO Lotion is the first and only tretinoin available in a lotion for acne. ALTRENO Lotion has been shown to be effective and generally well-tolerated, and is provided in a formulation with known moisturizers hyaluronic acid, glycerin and collagen.1

1. ALTRENO™ [prescribing information]. Bridgewater, NJ: Ortho Dermatologics.

October 15, 2018
ORTHO DERMATOLOGICS TO PRESENT NEW SCIENTIFIC DATA DURING THE FALL CLINICAL DERMATOLOGY CONFERENCE

16 Poster Presentations Include New Evaluations of Investigational and Existing Products

RALEIGH, N.C., Oct. 15, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the presentation of 16 posters during the Fall Clinical Dermatology Conference in Las Vegas, Oct. 18-21. The presentations will feature new analyses of the investigational drug DUOBRII™1 (halobetasol propionate and tazarotene) (IDP-118) Lotion—including long-term evaluations of safety and maintenance of treatment success—as well as new data on SILIQ™ (brodalumab) injection, ALTRENO™ (tretinoin) Lotion, 0.05%, and BRYHALI™ (halobetasol propionate) Lotion, 0.01%, which received tentative approval from the U.S. Food and Drug Administration (FDA) on Oct. 8, 2018. Please see below for SILIQ boxed warning about suicidal ideation and behavior.

1 – Provisional Name

October 11, 2018
ORTHO DERMATOLOGICS ANNOUNCES PUBLICATION OF PIVOTAL PHASE 3 EFFICACY AND SAFETY DATA ON ALTRENOTM (TRETINOIN) LOTION, 0.05% IN THE JOURNAL OF DRUGS IN DERMATOLOGY

ALTRENO Lotion Provides Statistically Significant Greater Efficacy Over Vehicle with a Favorable Safety and Tolerability Profile in Two Pivotal Clinical Trials1

RALEIGH, N.C., Oct. 11, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the Journal of Drugs in Dermatology has published results of two identical Phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel group studies examining the efficacy and safety of ALTRENOTM (tretinoin) Lotion, 0.05%, the first formulation of tretinoin, a retinoid, in a lotion indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.1 The U.S. Food and Drug Administration approved the New Drug Application for ALTRENO Lotion on Aug. 24, 2018.

October 8, 2018
ORTHO DERMATOLOGICS RECEIVES TENTATIVE FDA APPROVAL FOR BRYHALITM (HALOBETASOL PROPIONATE) LOTION, 0.01%, FOR PLAQUE PSORIASIS
IN ADULTS

In Clinical Trials, BRYHALI Lotion Demonstrated Significant Treatment Success Over Vehicle as Early as Week Two, Which Continued Through Week 12 (Four Weeks Post Treatment)1
New Corticosteroid Lotion Formulation with Safety Proven for Up to Eight Weeks Duration of Use1
Company Plans to Launch BRYHALI Lotion in November 2018 Upon Final FDA approval

RALEIGH, N.C., Oct. 8, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the U.S. Food and Drug Administration (FDA) has provided tentative approval of the New Drug Application for BRYHALITM (halobetasol propionate) Lotion, 0.01%, for the topical treatment of plaque psoriasis in adult patients. BRYHALI Lotion is a new potent to superpotent corticosteroid that contains 0.01 percent halobetasol propionate in a novel vehicle lotion. Its safety has been established in clinical trials with dosing for up to eight weeks with no increase in epidermal atrophy.1 The final FDA approval for BRYHALI Lotion is pending the expiration of exclusivity for a related product, which is expected in early November 2018. The company plans to launch BRYHALI shortly thereafter, as scheduled, in November 2018.

October 2, 2018
ORTHO DERMATOLOGICS ANNOUNCES PUBLICATION OF PIVOTAL PHASE 3 EFFICACY AND SAFETY DATA ON BRYHALITM (HALOBETASOL PROPIONATE) LOTION, 0.01% IN THE JOURNAL OF DRUGS IN DERMATOLOGY

Two Pivotal Trials Demonstrate the Efficacy of Investigational Drug BRYHALI Lotion Over Vehicle at Eight Weeks of Treatment, with Favorable Tolerability Profile1

RALEIGH, N.C., Oct. 2, 2018 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the Journal of Drugs in Dermatology has published results of two Phase 3 randomized controlled trials (Studies 1 and 2) examining the safety and efficacy of BRYHALITM* (halobetasol propionate) Lotion, 0.01%, an investigational potent to superpotent** corticosteroid, in the treatment of moderate-to-severe plaque psoriasis.1 BRYHALI Lotion has a Prescription Drug User Fee Act (PDUFA) action date of October 5, 2018.

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