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January 13, 2020
ORTHO DERMATOLOGICS ANNOUNCES PUBLICATION OF PIVOTAL PHASE 3 DATA ON ARAZLO™ (TAZAROTENE) LOTION, 0.045% IN THE JOURNAL OF DRUGS IN DERMATOLOGY (JDD)

ARAZLO Lotion Demonstrates Statistically Significant Superiority Over Placebo with Favorable Efficacy, Safety and Tolerability Profile

Post Hoc Analysis of the Two Phase 3 Studies Also Published in JDD

RALEIGH, N.C., Jan. 13, 2020 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the Journal of Drugs in Dermatology (JDD) published positive results from two large Phase 3, multicenter, double-blind, placebo-controlled clinical trials (Studies 1 and 2) demonstrating the efficacy, safety and tolerability of ARAZLO™ (tazarotene) Lotion, 0.045%, the first FDA approved tazarotene in lotion form for patients with moderate to severe acne.1 A post hoc analysis of male patients in the two Phase 3 studies was also published by JDD.2 The U.S. Food and Drug Administration (FDA) approved ARAZLO for the topical treatment of acne vulgaris in patients nine years of age and older in December 2019.

“When treating moderate to severe acne, I like to prescribe a tazarotene treatment due to the retinoid’s efficacy, but find patients often struggle with tolerability issues, such as dry, irritated skin,” said Emil A. Tanghetti, M.D., lead ARAZLO study investigator and founder, Center for Dermatology and Laser Surgery, Sacramento, Calif. “This newly published data sheds light on the utility of ARAZLO, a new treatment option that features the efficacy of tazarotene along with improved tolerability in a lotion vehicle, which is easily spreadable and aesthetically pleasing. I look forward to offering this treatment to my patients with acne in the coming months.”

December 19, 2019
FDA APPROVES ORTHO DERMATOLOGICS’ ARAZLO™ (TAZAROTENE) LOTION, 0.045%, FOR ACNE VULGARIS

First Tazarotene Acne Treatment Approved in Lotion Formulation

RALEIGH, N.C., Dec. 19, 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 ARAZLO™ (tazarotene) Lotion, 0.045%, for the topical treatment of acne vulgaris in patients nine years of age and older.1 ARAZLO is the first tazarotene acne treatment available in a lotion form, and has been shown to provide strong efficacy with favorable tolerability.

“Today’s approval of ARAZLO showcases our continued commitment to expanding our acne portfolio to help the approximately 50 million Americans who are impacted by this prevalent skin condition,” said Bill Humphries, president, Ortho Dermatologics. “As our fourth FDA approval in just 14 months, ARAZLO will provide dermatologists the efficacy expected of tazarotene in a new formulation that helps minimize the dryness and irritation historically associated with tazarotene use, which can cause many acne patients to discontinue treatment. We are purposely timing the launch of ARAZLO to coincide with the start of acne season in the first half of 2020.”

December 16, 2019
ORTHO DERMATOLOGICS ANNOUNCES NEW APPOINTMENTS IN SOLTA MEDICAL BUSINESS UNIT IN NORTH AMERICA

Several New Hires Reflect Ortho Dermatologics’ Continued Commitment to Addressing Patients’ Skincare Needs with Comprehensive Aesthetics Portfolio

RALEIGH, N.C., Dec. 16, 2019 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses in the world, today announced several recent new hires across its Solta Medical business unit. These business leaders will be dedicated to growing and expanding Solta’s comprehensive portfolio of products to meet the aesthetic needs of customers and patients in North America.

“We are proud to bring this strong and accomplished group of leaders together to lead our Solta Medical business in North America,” said Bill Humphries, president, Ortho Dermatologics. “Under Liz Panzica Newman, the general manager of Solta, I am confident that these individuals will positively contribute to our company’s growth as we continue to develop innovative treatment technologies that provide proven and effective aesthetic care options for doctors and patients.”

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

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