|Name/Company||Approval Dates and Comments|
Brimonidine tartrate 0.33% topical gel
Brimonidine 3 mg/g topical gel
Health Canada approved brimonidine tartrate 0.33% gel in February 2014 for the topical treatment of the facial erythema (redness) of rosacea in adults. It is not indicated for the treatment of inflammatory lesions (papules and pustules). Brimonidine is thought to work by constricting dilated facial blood vessels to reduce the redness of rosacea. Also in February 2014, the European Commission granted Marketing Authorization in Europe for brimonidine 3 mg/g gel (Mirvaso®). Brimonidine tartrate 0.33% gel (Mirvaso®) was US FDA approved in August 2013.
In March 2014 the FDA approved the first oral therapy for the treatment of adults with active psoriatic arthritis (PsA). Apremilast is an oral small molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, thereby suppressing immune responses. Safety and efficacy were evaluated in three clinical trials involving 1,493 patients with active PsA. Patients treated with apremilast showed improvement in signs and symptoms of PsA.
The FDA approved an abbreviated new drug application (ANDA) in January 2014 for fluocinonide cream 0.1% (innovator brand Vanos® cream 0.1%, Medicis, a division of Valeant Pharmaceuticals). Fluocinonide cream 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients ≥12 years of age.
Hydrogel wound dressing
The FDA approved this oral alkylphosphocholine antiparasitic agent in March 2014 for the treatment of three main types of leishmaniasis: visceral leishmaniasis (affects internal organs), cutaneous leishmaniasis (affects the skin) and mucosal leishmaniasis (affects the nose and throat). This oral alkyllysophospholipid analogue drug demonstrates in vitro activity against the promastigote and amastigote stages of Leishmania species. It is intended for use in patients ≥12 years of age. Impavido® is the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis.
Omalizumab for SC injection
The FDA approved omalizumab (a recombinant humanized monoclonal antibody that blocks the high-affinity Fc receptor of immunoglobulin E) in March 2014 for the treatment of chronic idiopathic urticaria (CIU). The new use (already approved for asthma) is for patients ≥12 years of age who remain symptomatic despite H1-antihistamine therapy. Treatment is not indicated for other forms of urticaria (hives). It is the first biologic medicine and first medicine approved by the FDA for CIU since nonsedating H1-antihistamines.
Propranolol hydrochloride oral solution
The FDA approved the first and only beta-blocker formulation in March 2014 for the treatment of proliferating infantile hemangioma requiring systemic therapy. Hemangeol™, specifically developed for use in pediatric patients, was studied in infants aged 5 weeks to 5 months (at therapy initiation) in a randomized, double-blind placebo-controlled, multi-dose and multicenter adaptive Phase 2/3 trial, which compared four propranolol treatment protocols (1 mg or 3 mg/kg/day for 3 or 6 months) vs. placebo. The treatment protocol of 3 mg/kg/day for 6 months demonstrated a 60.4% success rate vs. 3.6% in the placebo group, achieving the primary endpoint of complete or nearly-complete resolution.
Vivagel® (SPL7013 gel)
The Japanese Ministry of Health, Labour and Welfare granted marketing approval to Vivagel®-coated condom in March 2014. The product of nanotechnology, Vivagel® (active ingredient SPL7013) is a gel-based formulation of a proprietary dendrimer with both antibacterial and antiviral properties. In laboratory studies Vivagel® killed 99.9% of HIV, HPV, and HSV-2 (genital herpes virus).