Name/CompanyApproval Dates and Comments

Human Genome Sciences

Health Canada approved this new first-in-class human monoclonal antibody in August 2011 for the treatment of systemic lupus erythematosus (SLE). Treatment is indicated for adult patients with active, autoantibodypositive SLE who are receiving standard therapy. The drug inhibits the biological activity of the B-lymphocyte protein (BLyS). Elevated levels of BLyS are associated with autoimmune disorders and are believed to contribute to the production of autoantibodies that attack and destroy the body’s own healthy tissues. US FDA approval was granted in March 2011.
Generic and OTC Drugs

Tolnaftate 1% Cream


NexMed USA
Apricus Biosciences, Inc.
The US FDA confirmed that this over-the-counter antifungal compound is OTC monograph compliant for marketing in August 2011. This new formulation of tolnaftate uses the NexACT® drug delivery technology, which enhances the absorption of medications through the skin by transiently loosening the tight junction between skin cells to improve skin permeability and increase bioavailability. Tolnaftate is used to treat jock itch, athlete’s foot, and ringworm.

Hydrocortisone 1% Cream


NexMed USA
Apricus Biosciences, Inc.
The US FDA confirmed that this reformulated antipruritic compound is OTC monograph compliant for marketing in August 2011. The active ingredient, hydrocortisone, is combined with the proprietary drug technology NexACT® to improve drug permeation. Uses include the treatment of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, and psoriasis.

Ketoconazole 2% Foam

Perrigo Company
The US FDA granted approval in August 2011 to market this generic version of Stiefel’s antifungal product (Extina®) containing 2% ketoconazole in a foam formulation for the topical treatment of seborrheic dermatitis in patients ≥12 years of age.

Drug News
In September 2011, the US FDA announced that the boxed warning for the entire class of tumor necrosis factor alpha (TNF-alpha) inhibitors (e.g., adalimumab, certolizumab pegol, etanercept, golimumab, and infliximab) has been updated to include the increased risk for serious, and sometimes fatal, infection from two bacterial pathogens, Legionella and Listeria. A search of the FDA’s Adverse Event Reporting System (AERS) database between 1999 and 2010 found 80 patients who developed Legionella pneumonia after receiving anti-TNF therapy, including 14 deaths. In addition, the drugs have been associated with 26 cases of Listeria monocytogenes, including 7 fatalities. In many of these cases, patients were also using other immunosuppressive drugs (most commonly methotrexate and/or corticosteroids). The FDA further cautions that the risk for opportunistic infection may be higher in patients on concomitant treatment with immunosuppressive agents and in individuals >65 years of age. In 2008, the FDA mandated the strengthening of label warnings on TNF-alpha antagonists to include the increased risk for histoplasmosis and other invasive fungal infections.