ClassName/CompanyApproval Dates and Comments

Ketoconazole 2% Gel


Barrier Therapeutics

The US FDA approved this antifungal agent in July 2006 for the topical treatment of seborrheic dermatitis in immunocompetent adults and children > =12 years of age. Xolegel is the first prescription gel formulation of ketoconazole approved in the US.

Antipsoriatic Agent



The US FDA approved this antiTNF-á agent in September 2006 for the treatment of adult patients with chronic severe (i.e., extensive or disabling) plaque psoriasis, who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. The recommended dose is an infusion of 5mg/kg followed by additional doses at 2 and 6 weeks after the first infusion and then every 8 weeks thereafter.

Quadrivalent Human Papillomavirus Recombinant Vaccine



The European Union approved this vaccine in September 2006 for use in children and adolescents aged 9-15 years and in adult females aged 16-26 years for the prevention of cervical cancer and high-grade cervical dysplasias/ precancers caused by human papillomavirus (HPV) types 6, 11, 16 and 18.

Atopic Dermatitis Agent
Verdeso Foam 0.05%
The US FDA approved this low-potency topical steroid for the treatment of mild-to-moderate atopic dermatitis. This product, previously referred to as Desilux is the first approved product formulated in Connetics’ VersaFoam®-EF emulsion formulation foam vehicle.

Drug News

Antiacne Agent
In an October 2006 Dear Healthcare Professional letter from the US FDA and the iPLEDGE program, healthcare professionals and patients were notified of an update to iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin (Accutane®, Hoffmann-La Roche). One element of the program will be eliminated: the 23 day lock-out period for males and females of nonchildbearing potential, which will allow these patients the ability to have a new prescription filled after the 7-day window has expired. However, both the patient and prescriber must complete the qualification process again to ensure the patient has met all qualification criteria, including confirming patient counseling in the iPLEDGE system. For additional information visit: http://www.ipledgeprogram.com/.

A team of researchers has developed a model for estimating the 5-year risk of melanoma, which can be used by health professionals to identify individuals with a higher risk of this deadly skin cancer and to help them plan for potential interventions. The gender-specific model uses information on skin complexion and sun exposure, and a physical examination of the back and shoulders to estimate the probability of an individual developing the first primary melanoma. The model is designed for physicians to assess nonHispanic white men and women between 20 and 70 years of age. It is not intended to assess the risk of individuals with a prior melanoma or nonmelanoma skin cancer or for those with a family history of melanoma, because they are already recognized as being at higher risk. The tool is available at http://www.cancer.gov/melanomarisktool.
Source: *Fears TR, Guerry D 4th, Pfeiffer RM, et al. J Clin Ocol 24(22):3590-6 (2006 Aug).