June 23, 2020
ORTHO DERMATOLOGICS ANNOUNCES ARAZLO™ (TAZAROTENE) LOTION, 0.045%, NOW AVAILABLE IN THE U.S.
ARAZLO™ (tazarotene) Lotion, 0.045% is Indicated for the Topical Treatment of Acne Vulgaris in Patients Nine Years of Age and Older
RALEIGH, N.C., June 23, 2020 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that ARAZLO™ (tazarotene) Lotion, 0.045%, is available commercially to health care professionals starting this week. Approved by the U.S. Food and Drug Administration
(FDA) in December 2019, ARAZLO is the first tazarotene acne treatment available in lotion formulation.
April 29, 2020
FDA APPROVES ORTHO DERMATOLOGICS’ LABELING FOR JUBLIA® (EFINACONAZOLE) TOPICAL SOLUTION, 10%, IN PATIENTS AS YOUNG AS SIX YEARS OLD
RALEIGH, N.C., April 29, 2020 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for JUBLIA® (efinaconazole) topical solution, 10%, a treatment for onychomycosis, a fungal infection of the toenails, which extends the age range included in the product’s label to children six years of age and older.1 JUBLIA was first approved in June 2014 in patients 18 years and older.
“Onychomycosis is increasingly being seen in pediatrics – representing 15 percent of all nail dystrophies in children,”2 said Bill Humphries, president, Ortho Dermatologics. “With nearly six years of real-world use since its initial approval to treat adults in 2014, JUBLIA has a demonstrated safety and efficacy profile, and we are pleased the FDA has recognized it as a valuable treatment option for children with toenail fungal infections.”
February 18, 2020
ORTHO DERMATOLOGICS EXPANDS CASH-PAY PROGRAM, DERMATOLOGY.COM
RALEIGH, N.C., Feb. 18, 2020 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced an expansion of Dermatology.com, the first and only non-reimbursed, cash-pay program in dermatology in the United States. Four products have been added to the program, which include RENOVA® (tretinoin cream 0.02%), LOPROX® shampoo (ciclopirox 1%), SOLODYN® (minocycline hydrochloride) extended release tablets and the program’s first over-the-counter option, BenzEFoam® (benzoyl peroxide emollient foam 5.3%/9.8%). A new telemedicine platform has also been added, offering patients the ability to consult with a health care professional, order and potentially receive a prescription on-demand for many of the branded dermatology products available in the program.1 Some products, such as SOLODYN® (minocycline hydrochloride) extended release tablets, EFUDEX® (fluorouracil) topical cream, 5%, and ALDARA® (imiquimod) cream, 5%, which are for more serious skin conditions, will require an in-office visit instead.
“We launched Dermatology.com in March 2019 to provide physicians and patients access to proven, branded treatment options for certain disease states that typically encounter coverage hassles and challenges like acne and barrier repair,” said Bill Humphries, president, Ortho Dermatologics. “Now, with the telemedicine platform, the program is making it possible for patients to receive high-quality, well-known, FDA-approved treatments in a convenient, on-demand manner while, at the same time, ensuring patients are directed to see a board-certified dermatologist when their skin conditions require an in-office visit.”
February 3, 2020
ORTHO DERMATOLOGICS OPENS 2020 ASPIRE HIGHER SCHOLARSHIP PROGRAM
Students Treated for Dermatologic Conditions Can Apply for the Scholarship Through April 27, 2020
RALEIGH, N.C., Feb. 3 2020 – Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the opening of the application process for its 2020 Aspire Higher scholarship program. The program, which began in 2012, will award nine students who have been treated for a dermatologic condition with a $10,000 scholarship in support of their academic goals.
“The role of a student today can be overwhelming – from managing their academics to extracurricular activities, work studies and more. Adding the physical and emotional burden of living with a skin condition, which is generally visible to see unlike other medical diseases, can make it even more difficult, which is why the relationship they have with their dermatologist is critically important to help them properly address their skincare needs,” said Bill Humphries, president, Ortho Dermatologics. “We remain committed to continuing the Aspire Higher program and look forward each year to providing more students who have been challenged by a skincare condition with the support they need to pursue their higher education.”
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.