Class Name/Company Approval Dates and Comments

Antifungal Agent


Ketoconazole


Ketoderm® Cream 2%

OptimaPharma

TPP – Canada approved this topical antifungal agent in April 2002, for the treatment of fungal infections of the skin. It is a prescription product that is bioequivalent to Nizoral® Cream (McNeil Consumer Products).

Anti-acne Agent


Benzoyl Peroxide, Clindamycin


DUAC® Topical Gel

Stiefel Laboratories

The US FDA approved this anti-acne agent in August 2002, for the treatment of acne vulgaris.

Antiviral Agent


Trans-Ver-Sal® Wart Removal Patch

Bradley Pharmaceuticals

The Swedish Medical Products Agency approved this product in June 2002. Sweden is the first EU member country to market this wart removal patch under the new EU regulations.

HIV/AIDS


Rubitecan


Orathecin™

SuperGen

The US FDA issued orphan-drug designation in July 2002, for the treatment of pediatric patients infected with HIV and AIDS.

Antihistamine


Loratidine


Claritin® 10mg Tablets

Schering-Plough KK

The Ministry of Health, Labor and Welfare (MHLW) in Japan approved this antihistamine in July 2002, for the treatment of allergic rhinitis, chronic idiopathic urticaria and itching associated with skin diseases in adults and children 15 years and older.


Drug News

Smoking and Basal Cell Carcinoma

Smoking can play a key role in the differentiation of basal cell carcinoma (BCC) toward its sclerosing form, according to a recent article in the International Journal of Dermatology*. In a retrospective study of 34 patients with morpheaform BCC, and 50 patients with solid BCC, Erbagci and Erkilic investigated the possible roles of smoking and occupational UV exposure in the development of morepheaform BCC, through the quantification of peritumoral mast cells. Increased mast cell indices were associated with smoking (p=0.003), but not with UV exposure (p>0.05).
*Int J Dermatol 41(5):275-8 (2002 May).

Actinic
Keratosis Agent

In May 2002, SkyePharma PLC transferred all rights to market Solaraze® in Europe to Shire Pharmaceuticals. This product is a topical therapy for actinic keratosis that has been approved for marketing in several European countries including the UK, Germany and Sweden.