Name/CompanyApproval Dates/Comments
Evolus/Clarion Medical
In August 2018, Health Canada approved prabotulinumtoxinA, a 900 kDa purified botulinum toxin type A complex, for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows seen at maximum frown) in adult patients <65 years of age.
Tretinoin 0.05% lotion
Ortho Dermatologics
The US FDA approved tretinoin 0.05% lotion in August 2018 for the topical treatment of acne vulgaris in patients ≥9 years of age. This is the first formulation of tretinoin in a lotion, and it includes hyaluronic acid, glycerin and collagen for enhanced moisturization.
Cemiplimab-rwlc for IV use
The FDA approved this fully-human monoclonal antibody in September 2018 for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Cemiplimab-rwlc targets the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the first and only treatment specifically approved for advanced CSCC in the US.
Autologous fibroblast gene therapy
Fibrocell Science
In September 2018, the FDA granted Fast Track designation to FCX-013 for the treatment of moderate to severe localized scleroderma. FCX-013 is an autologous fibroblast genetically modified using lentivirus and encoded for matrix metalloproteinase 1 (MMP-1). The treatment is injected under the skin at the site of lesions where the fibroblast cells will produce MMP-1 to break down excess collagen accumulation.
Oral JAK3 inhibitor
In September 2018, the FDA granted Breakthrough Therapy designation to this investigational oral Janus kinase 3 (JAK3) inhibitor for the treatment of patients with alopecia areata. PF-06651600 is an oral small molecule that selectively inhibits JAK3. The JAK pathways are believed to play a key role in inflammatory processes, as they are involved in signaling for a number of cytokines and growth factors, many of which drive immune-mediated conditions.
Halobetasol propionate 0.01% lotion
Ortho Dermatologics
In October 2018, the FDA provided tentative approval of the New Drug Application for halobetasol propionate lotion 0.01% for the topical treatment of plaque psoriasis in adult patients. This preparation is a new potent to superpotent corticosteroid that contains 0.01% halobetasol propionate in a novel vehicle lotion. Safety was demonstrated in clinical trials for up to 8 weeks use with no increase in epidermal atrophy.
Sarecycline hydrochloride tablets
The FDA approved sarecycline in October 2018 for treating inflammatory lesions of non-nodular, moderate to severe acne vulgaris in patients aged ≥9 years. Sarecycline is a new first-inclass, once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties.
HPV 9-valent vaccine, recombinant
Merck, Sharp & Dohme
In October 2018, the FDA approved a supplemental application for Gardasil®9 (human papillomavirus [HPV] 9-valent vaccine, recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil®9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine. Previously, the vaccine was only indicated in people aged 9 through 26.

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