ClassName/CompanyApproval Dates and Comments

Antiacne Agent
Clindamycin Phosphate 1.2%/ Tretinoin 0.025%
Ziana™ Gel
Medicis/ Dow Pharmaceuticals
The US FDA approved this gel formulation in November 2006 for once daily use for the topical treatment of acne vulgaris in patients 12 years or older.

Monoclonal Antibody
Abbott Pharmaceuticals
The US FDA approved an expanded indication in November 2006 that includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis. This expanded indication is in addition to the psoriatic arthritis approval granted in October 2005.

Photodynamic Therapy
Aminolevulinic Acid/ Light
Levulan® Kerastick®
DUSA Pharmaceuticals/Stiefel Laboratories
The Brazilian drug regulatory authority, ANVISA, approved this product in October 2006 for the treatment of precancerous actinic keratoses.

Oncologic Agent
Oblimersen Sodium Injection
The Australian drug regulatory authority, the Therapeutic Goods Administration, granted Orphan Drug designation in October 2006 for the use of this anticancer drug as treatment for patients with Stage IV malignant melanoma.

Monoclonal Antibody
UCB/ Immunomedics
In November 2006, the US FDA lifted the clinical hold on existing trials with this monoclonal antibody in patients with lupus. Protocol amendments will be submitted to Institutional Review Boards to seek approval to treat patients who remain on the currently suspended studies and who are in need of retreatment.

Drug News

Drug Warning
The US FDA is alerting health care professionals and patients treated with rituximab (Rituxan®, Genentech/ Biogen Idec) to reports of an emerging risk of a serious side-effect in patients receiving, or who have used rituximab. Two patients who were treated with this drug for systemic lupus erythematosus (SLE) developed progressive multifocal leukoencephalopathy, a fatal viral infection of the central nervous system. This side-effect has been reported in patients as late as 12 months after their last dose. SLE is not an approved indication for rituximab; it is approved only for the treatment of patients with non-Hodgkin’s lymphoma and patients with rheumatoid arthritis whose disease no longer responds to other common treatments. Health care professionals should report any serious adverse events possibly associated with the use of rituximab to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm, or by phone at 1-800-FDA-1088.

Psoriasis and Myocardial Infarction
In an article recently published in JAMA*, Gelfand, et al. report that psoriasis is an independent risk factor for myocardial infarction, and this risk is greatest in young patients with severe psoriasis. The authors conducted a large, prospective population-based cohort study to determine the risk of heart attack in patients aged 20-90 years with psoriasis while controlling for major cardiovascular risk factors.*Gelfand JM, et al. JAMA 296(14):1735-41 (2006 Oct).