Product Review

Product News July 2020


 

Arazlo Now Available in the United States

Ortho Dermatologics launches Arazlo (tazarotene) Lotion 0.045% to health care professionals in the United States. Arazlo was approved by the US Food and Drug Administration in December 2019 for the treatment of acne in patients 9 years and older. Clinical trials indicated that Arazlo Lotion offers a tolerable formulation without sacrificing efficacy. For more information, visit arazlo.com/hcp/.

FDA Approves Updated Label for Seysara Tablets

Almirall, LLC, receives US Food and Drug Administration (FDA) approval for an update to the Seysara (sarecycline) Tablets label stating that Propionibacterium acnes strains displayed a low propensity for the development of resistance to sarecycline, which is important when considering the appropriate use of antibiotics. The FDA approved Seysara in 2018 for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years and older. For more information, visit seysara.com.

Jublia Labeling Extends to Pediatric Patients

Ortho Dermatologics announces the US Food and Drug Administration has approved a supplemental New Drug Application for Jublia (efinaconazole) Solution 10% for the treatment of onychomycosis in patients 6 years and older. Jublia was initially approved in 2014 for patients 18 years and older. With its safety and efficacy profile demonstrated in real-world use over the last 6 years, Jublia can now be a valuable treatment option for children with toenail fungal infections. For more information, visit jubliarx.com.

Revance and Mylan to Develop Biosimilar to Botox

Revance Therapeutics, Inc, and Mylan N.V. announce they are moving forward with a 351(k) development plan for a proposed biosimilar to Botox and Botox Cosmetic (onabotulinumtoxinA), which would allow Revance to financially participate in the short-acting neurotoxin space while focusing commercial efforts in the long-acting neuromodulator category. Mylan will handle the commercialization of the new biosimilar in the United States, Europe, and other markets worldwide. For more information, visit revance.com and mylan.com.

The Skin Cancer Foundation Awards $125,000 in Research Grants

The Skin Cancer Foundation awards $125,000 in grants to 3 separate researchers who submitted proposals to further prevention, early detection, and treatment of skin cancer. Matthew Hangauer, PhD (La Jolla, California), received $50,000 for “Targeting Immunotherapy-Tolerant Melanoma Persister Cells”; Lee E. Wheless, MD, PhD (Nashville, Tennessee), received $50,000 for “Using Bioinformatics to Stratify Skin Cancer Risk in Organ Transplant Recipients”; and Vishal Patel, MD (Washington, DC), received $25,000 for “Delphi Consensus Determination of a Tumor Stage Based Approach to High-Risk Cutaneous Squamous Cell Carcinoma.” The Skin Cancer Foundation’s Research Grants program helps provide funding for studies that have led to lifesaving breakthroughs. The 2021 research grants application period will open soon. For more information, visit SkinCancer.org/research.

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