|Name/Company||Approval Dates and Comments|
Trametinib + Dabrafenib
Mekinist® + Tafinlar®
The US FDA granted accelerated approval in January 2014 to trametinib in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations. Approval of the combination therapy is based on the demonstration of response rate and median duration of response in a multicenter, open-label, randomized, active-controlled, dose-ranging phase I/II trial, which compared combination trametinib and dabrafenib to dabrafenib monotherapy. The overall response rate was 76% (95% confidence interval [CI]; 62, 87) with combination therapy compared to 54% (95% CI; 40, 67) with dabrafenib alone. The median duration of response was 10.5 months (95% CI; 7, 15) with combination therapy compared to 5.6 months (95% CI; 5, 7) with monotherapy. Improvement in diseaserelated symptoms or overall survival has not yet been shown. The accelerated approval is contingent on the results of the ongoing phase III trial evaluating the clinical benefit of this dual combination treatment.
Tretinoin gel microsphere 0.08%
The FDA approved a Supplemental New Drug Application (sNDA) in January 2014 for Retin-A Micro® gel microsphere 0.08% for the topical treatment of acne vulgaris. Retin-A Micro® gel is already available in 0.04% and 0.1% strengths.
Fluocinonide cream 0.1%
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
In January 2014, Acella Pharmaceuticals announced the successful FDA 510(k) marketing clearance and launch of Loutrex® Topical Cream. This prescription medical device product is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain.
FDA 510(k) clearance was granted in December 2013 to Microcyn® Scar Management HydroGel, a prescription product for the management of old and new hypertrophic and keloid scarring resulting from burns, general surgical procedures and trauma wounds.
In January 2014, the FDA issued a warning to consumers and healthcare professionals that flammable over-the-counter wart removers have started fires, resulting in injuries to at least 10 people, who suffered singed hair, blisters, burns or skin redness. Since 2009, the FDA has received 14 reports about some cryogenic wart removers. In several cases, combustion occurred when the products (a mixture of liquid dimethyl ether and propane) were used near a candle. In 3 of the reports to the FDA, there was a candle nearby, but no ignition source was identified in the other 11 reports. Labeling for these products clearly states that they are flammable and should be kept away from fire, flame, heat sources, and cigarettes. In the incidents reported to the FDA, the wart remover dispenser generally caught fire when the mixture was being released.