|Approval Dates and Comments
Adapalene 0.3% gel
The US FDA approved a pump dispenser in March 2012 for this retinoid gel formulation for the topical treatment of acne vulgaris in patients 12 years of age or older. A survey study reported that patients found the pump dispenser to be more convenient and easier to use compared with the tube. More than 90% of surveyed patients found the pump to deliver a consistent amount of the gel for application and saved time during treatment application.
|Generic and OTC Drugs
Health Canada approved this oral, small molecule, protein kinase inhibitor in March 2012 for the treatment of adult patients with BRAFV600 mutation-positive unresectable or metastatic melanoma. This BRAF enzyme inhibitor was approved with a companion diagnostic called the cobas® 4800 BRAF V600 Mutation Test, which determines a patient’s eligibility for treatment.
The European Commission granted CE Mark of approval (as a class III medical product) in April 2012 to this hemoglobin spray (also known as HEMO2SPRAY®) for improving the healing of chronic wounds by increasing oxygen supply.
Laser device for onychomycosis
US FDA clearance was granted to this aesthetic laser device for the treatment of onychomycosis in March 2012. This dual wavelength system utilizes two distinct Q-switched laser technologies, neodymium:yttrium-aluminum-garnet (Nd:YAG) 1064 nm with its potassium titanyl phosphate (KTP) 532 nm tip, to create microcavitations and acoustic shock waves on the surface of the nail plate that are transmitted to the nail bed, causing mechanical damage to the irradiated fungal colony and inducing decapsulation of spores. The green light emitted by the Q-switched KTP 532 nm laser is selectively absorbed by red and brown pigments of the fungal infection, whereas the Nd:YAG 1064 nm laser causes nonspecific heat conduction on the entire nail, which induces thermal destruction of the microorganisms.
On April 11, 2012, the US FDA announced changes to the labels for finasteride 1 mg (Propecia®) and finasteride 5 mg (Proscar®) to include a wider list of reported sexual adverse events. Such events have been reported to persist after discontinuation of therapy. In 2011, the labels of both finasteride 5 mg and 1 mg formulations were amended to include erectile dysfunction. Proscar® is used to treat benign prostatic hyperplasia, while Propecia® is indicated for treating androgenic alopecia in men, and is also used off-label for hirsutism in women. Revised labelling changes include:
The FDA states that although “clear causal links between finasteride and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs.” Controlled studies showed that a small percentage of men using Propecia® 36 (3.8%) of 945 had reported one or more adverse sexual experiences vs. 20 (2.1%) of 934 on placebo. The FDA recommends that healthcare professionals and patients should consider this new label information when making treatment decisions.