Trifarotene 0.005% cream

Trade Name: Aklief®
Company: Galderma

Approval Dates/Comments: The US FDA approved trifarotene 0.005% cream in October 2019 for the topical treatment of acne vulgaris. Trifarotene is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin. Stimulation of RAR results in alterations of target genes that are associated with various processes, including cell differentiation and mediation of inflammation. This RAR gamma agonist is the first topical treatment specifically shown to treat both facial (forehead, cheeks, nose and chin) and truncal (chest, shoulders and back) acne. Trifarotene is the first new retinoid molecule to receive FDA approval for the treatment of acne in more than 20 years.

Afamelanotide implant

Trade Name: Scenesse®
Company: Clinuvel Pharmaceuticals

Approval Dates/Comments: In October 2019, the FDA approved afamelanotide, a selective agonist of the melanocortin 1 receptor (MC1R) indicated for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). Treatment with afamelanotide increases pain-free light exposure in patients with a history of phototoxic reactions (i.e., damage to skin) from EPP. The drug was approved in Europe in December 2014.

Rituximab for IV use

Trade Name: Rituxan®
Company: Genentech

Approval Dates/Comments: In September 2019, the FDA approved this CD20-directed cytolytic antibody indicated for the treatment of adult patients with granulomatosis with polyangiitis (GPA) (formerly known as Wegener’s granulomatosis) and microscopic polyangiitis (MPA) in children ≥2 years of age in combination with glucocorticoids. It is the first approved treatment for children with these rare vasculitis diseases, in which a patient’s small blood vessels become inflamed, reducing the amount of blood that can flow through them, resulting in damage to organs, primarily the lungs and kidneys. It also can impact the sinuses and skin.

Smallpox and monkeypox vaccine, live, attenuated, nonreplicating (MVA-BN®, liquid-frozen) for SC use

Trade Name: Jynneos™
Company: Bavarian Nordic

Approval Dates/Comments: In September 2019, the FDA approved Jynneos™ for prevention of smallpox and monkeypox disease in adults aged ≥18 years determined to be at high risk for smallpox or monkeypox infection, which have been increasingly viewed as bioterrorism threats. This is the only approved non-replicating smallpox vaccine in the US and the only approved monkeypox vaccine worldwide. The approved indication covers a broad patient range, including individuals with weakened immune systems and those with atopic dermatitis (AD, eczema) or with household members with AD.

Dapsone 7.5% gel

Trade Name: Aczone®
Company: Almirall

Approval Dates/Comments: The FDA approved an expanded indication for dapsone 7.5% gel in September 2019 to include patients aged 9-11 years for the treatment of inflammatory and non-inflammatory acne. It was approved in February 2016 for patients aged ≥12 years.

Injectable hyaluronic acid dermal filler

Trade Name: Juvéderm Voluma® XC
Company: Allergan

Approval Dates/Comments: In September 2019, the FDA approved the use of this hyaluronic acid gel dermal filler, with a TSK STERiGLIDE™ cannula, for cheek augmentation to correct age-related volume deficit in the mid-face in adults >21 years of age. The TSK STERiGLIDE™ has a unique design compared to other cannulas available on the market and features a patented tip design with a near-tip delivery port for precise product placement.

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