|Name/Company||Approval Dates and Comments|
Hyaluronic acid gel dermal filler
The US FDA approved this first and only crosslinked hyaluronic +acid gel filler in October 2013 for the temporary correction of age-related volume loss in the cheek area in adults >21 years of age. Treatment is indicated for deep (subcutaneous and/or supraperiosteal) injection into facial tissue to temporarily restore volume and fullness to the areas of the mid-face, which include the cheeks and nearby regions confined to the middle portion of the face. In clinical trials, 86% of subjects demonstrated an improvement in their cheek fullness at 6 months, and results lasted up to 2 years in a majority of subjects. Most subjects experienced moderate tenderness, swelling, firmness and/ or lumps and bumps at the injection site that generally lasted 2-4 weeks. Juvéderm Voluma™ XC is formulated using the proprietary Vycross™ technology, which allows the gel to be injected smoothly and consistently through a needle or microcannula. It also contains the local anesthetic, lidocaine, to limit discomfort.
The FDA approved subcutaneous (SC) methotrexate (MTX) in October 2013 for symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy in adults. The FDA also approved the use of Otrexup™ for treating adults with active, severe rheumatoid arthritis who have shown an insufficient therapeutic response to or are intolerant of first-line therapy, including full dose nonsteroidal anti-inflammatory agents (NSAIDs), or children with active polyarticular juvenile idiopathic arthritis. It is the first FDA-approved SC MTX for once-weekly self-administration delivered with a single-dose, disposable auto injector.
Luliconazole 1% cream
The FDA approved luliconazole, a novel imidazole drug, in November 2013 for the topical treatment of athlete’s foot (interdigital tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients ≥18 years of age. This is the first topical, broad-spectrum, azole antifungal agent approved to treat tinea cruris and tinea corporis with a one-week, once-daily treatment regimen. All other approved treatments require two weeks of therapy. Interdigital tinea pedis is approved with a two-week, once-daily regimen. This US approval is the first regulatory approval in North America. Luliconazole has been sanctioned in Japan since 2005.
Health Canada granted a Notice of Compliance in November 2013 approving Imvamune® for active immunization against smallpox in a public health emergency. Treatment is indicated for persons ≥18 years of age who are contraindicated to replicating smallpox vaccines, including individuals with immune deficiencies and skin disorders.