|Approval Dates and Comments
The US FDA approved this anti-inflammatory agent in January 2002, for the short-term treatment of moderate-to-severe melasma of the face, combined with sun avoidance measures that include the use of sunscreens.
Atopic Dermatitis Agent
The Danish Medicines Agency approved this non-steroid atopic dermatitis agent in March 2002, for patients from as young as 3 months of age through to adulthood. Denmark is the first country in Europe to approve this cream.
The UK Medicines Control Agency approved this ant-acne agent in Feb 2002, for the treatment of acne. Zindaclin™ is a clindamycin zinc complex in a gel formulation that has a prolonged residence in the skin, thereby reducing systemic absorption and its associated side-effects. Clinical studies demonstrated that once-daily dosing was equivalent to the twice per day application required by the market-leading clindamycin product.
The European Commission of the European Union authorized marketing of both the oral and IV formulations of this antifungal agent in March 2002, for treatment in immunocompromised patients with progressive, possible life-threatening infections that include acute invasive aspergillosis; fluconazole-resistant invasive Candida; and serious fungal infections caused by Scedosporium spp. and Fusarium spp.
The US FDA approved a broader indication for this antiviral agent in March 2002, to include adolescents 12 years of age and older for treatment of external genital warts. It was previously approved for patients 18 years and older.
Ten patients with moccasin tinea pedis, a hard-to-treat chronic foot fungus all recovered following treatment with Carmol 40® cream (40% urea, Bradley Pharmaceuticals) combined with ciclopirox cream. A larger study is planned to verify the findings. In vitro studies had shown synergy between Carmol 40® and ciclopirox, i.e., the two compounds alone significantly reduced fungus counts after three days, but completely eradicated the fungus within 6 hours when given together.
Human Papilloma Virus
According to a recent large-scale study of women in western Washington in the US, infection with HPV can be a serious risk factor for vaginal cancer. Like cervical and other anogenital cancers, vaginal cancer was found to be strongly associated with prior infection of this virus. The results, published in Gynecologic Oncology*, suggest that women with genital warts should be monitored for the development of multiple anogenital cancers.