UPDATE ON DRUGS

ClassName/CompanyApproval Dates and Comments

Antibacterial Agent
Minocycline HCl

SOLODYN™ Extended
Release Tablets


Medicis

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
Linezolid

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
Tigecycline

Tygacil®


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
CF-1743


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).