ClassName/CompanyApproval Dates and Comments


VANOS™ 0.1%


The US FDA approved an additional indication in March 2006 for this class I
corticosteroid as a primary therapy for all inflammatory and pruritic skin conditions,
including eczema and poison ivy, in patients 12 years of age or older who are
responsive to corticosteroids. It was originally indicated for the treatment of plaquetype

Antiarthritic Agent



The Australian Health Regulators approved an additional indication for this
biologic therapy in March 2006 for the treatment of psoriatic arthritis.The US FDA granted priority review of this biologic therapy in April 2006 for
the treatment of moderate-to-severe active pediatric Chrohn’s disease in patients
who have had an inadequate response to conventional therapies.

Antibacterial Agent



The EMEA’s Committee for Medicinal Products for Human Use recommended
approval of this new class of antibiotics in March 2006 for the treatment of
complicated skin and soft-tissue infections and complicated intra-abdominal

Drug News

Drug Warning
Finalizing a safety review of tacrolimus (Protopic®, Astellas) and pimecrolimus (Elidel®, Novartis) that
began in April 2005, the EMEA’s Committee for Medicinal Products for Human Use concluded that the
benefits associated with the use of these dermatological medicinal products outweigh the risks, but that
they should be used with greater caution in order to reduce potential risks of skin cancer and lymphoma as
far as possible. The Committee recommended changes to the current product information, aimed at raising
awareness of the potential long-term risks. They requested that the companies gather more data on the longterm
safety profile.

Industry News
Metronidazole (MetroGel® 0.75%, Galderma) has been a mainstay for the treatment of rosacea. In July 2005,
MetroGel® 1% was approved by the US FDA. It incorporates a higher concentration of metronidazole,
allowing for a once-daily dosing as opposed to the twice-daily dosing required by most other rosacea
treatments. Galderma reports that a new 60gm size is now available, and that they are no longer marketing
the 0.75% formulation.

Industry News
Penciclovir 1% cream (Denavir®), which is approved in Canada for the treatment of outbreaks of herpes
labialis in adults, is now being distributed by Barrier Therapeutics. It is the only topical antiviral prescription
product approved by Health Canada for treating this condition..

Systemic Lupus
A study recently published in the New England Journal of Medicine* reported that women with either
inactive or stable systemic lupus erythematosus were able to take oral contraceptives without increased risk
of flares. Subjects who took triphasic 35ìg ethinylestradiol/0.5-1mg norethindrone for twelve 28-day cycles
had no statistically significant difference in the occurrence of flares than those taking placebo. Severe flares
occurred in about 7% of the women, regardless of whether they received oral contraceptives or placebo.
*Petri M, et al. N Engl J Med 353:2550-8 (2005).