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Update on Drugs and Drug News - June 2006




Approval Dates and Comments

Antibacterial Agent

Minocycline HCl
SOLODYN™ Extended Release Tablets

The US FDA approved this once-daily oral antibiotic in May 2006 for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 12 years of age and older. SOLODYN™ is not bioequivalent to any other minocycline product.

Antibacterial Agent

ZYVOX® 600mg
Pfizer Japan

Japan’s Ministry of Health, Labor and Welfare approved a new indication in April 2006 for this antibacterial agent. It is now available for the treatment of infections associated with methicillin-resistant Staphylococcus aureus (MRSA).

Antibacterial Agent

Wyeth Pharmaceuticals

The EMEA’s Committee for Medicinal Products for Human Use approved this antibiotic in May 2006 for use in complicated infections of the skin and soft tissue that were hospital or community acquired. This product is in a new class of antibiotics called glycylcyclines and has in vitro activity against many Gram-positive and Gram-negative bacteria, including MRSA.

Antiviral Agent


FermaVir Pharmaceuticals

The US FDA accepted an Investigational New Drug application in May 2006 for preclinical and clinical studies related to a novel antiviral drug candidate for the treatment of shingles.

Drug News

Antipsoriatic Agent

In April 2006, Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) became available by prescription in the US. The US FDA approved this once-daily topical ointment in January 2006 for the treatment of psoriasis vulgaris in adults 18 years of age and older for up to 4 weeks.

Research News

A new meta-analysis of previous studies of tumor necrosis factor (TNF)-blocking antibodies, recently published in the Journal of the American Medical Association*, found an increased risk of serious infections and a dose-dependent increased risk of malignancies in patients with rheumatoid arthritis. Collectively, using various types of analyses, the researchers found that those treated with TNF-blocking antibodies had 3.3 times the risk of developing cancer than those given placebo, and 2.0 times the risk of serious infection. Cancers were much more common in those patients treated with high doses of TNF-blocking antibodies. These drugs are also used to treat psoriasis, psoriatic arthritis, and Crohn’s disease. *Bongartz T, et al. JAMA 295(19):2275-85 (2006 May 17).

Research News

According to a study published in the February issue of the International Journal of Dermatology*, using makeup to cover a severe facial blemish may not improve the quality of a woman’s life. Using the Skindex-16 and the Fear of Negative Evaluation assessment tools, the investigators found that severe facial blemishes of any cause have a significant impact on women’s quality of life, and the effect of these lesions is mediated in part by psychological characteristics related to self-perception and self-presentation. They also found that women who did not use foundation, while they represented only 10% of the study population, had better health-related quality of life than those who did. *Balkrishnan R, et al. Int J Dermatol 45(2):111 (2006 Feb).

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