ClassName/CompanyApproval Dates and Comments

Antipsoriatic Agent
Dipropionate Ointment
Warner Chilcott/LEO
The US FDA approved this product in January 2006 as a once daily
treatment for psoriasis vulgaris in adults. This ointment is marketed as
Dovobet® and Daivobet® outside of the US.

Antipsoriatic Agent



TPP Canada approved this biologic therapy in December 2005 for
the treatment of moderate-to-severe psoriasis in adults. It has been
previously approved in Canada for the treatment of rheumatoid
arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, and
ankylosing spondylitis.

Drug News

Updated Labeling
The US FDA, in January 2006, approved updated labeling for two eczema drugs, pimecrolimus
(Elidel®, Novartis), and tacrolimus (Protopic®, Astellas Pharma). The new labeling will include a
boxed warning about a possible risk of cancer, informing healthcare professionals that the longterm
safety of these drugs has not been established, though studies are underway and there is a
recognized benefit associated with these drugs when used appropriately. The new labeling also
clarifies that these drugs are recommended for use as second-line treatments. Use of these drugs in
children < 2years of age is not recommended. A Medication Guide has been published that provides
consumer friendly information to patients about how to use the drugs safely. Pharmacists are
required to provide the Medication Guide to patients when dispensing the drug.

Dear Doctor Letter
In January 2006, HPB Canada sent out a Dear Healthcare Professional letter concerning hepatitis
B virus relapse in all TNF blocking agents, including etanercept (Enbrel®, Amgen Canada/Wyeth
Pharmaceuticals), adalimumab (Humira®, Abbott) and infliximab (Remicade®, Centocor). These effects
are very rare (< 1 adverse event/10,000 treated patients) and are not unique to the anti-TNF-á products,
having been reported for other immunosuppressive agents as well. Patients at risk for HBV infection
should be evaluated for prior evidence of HBV infection before beginning therapy with any anti-TNF-á
product. Those patients identified as carriers of HBV should be monitored for signs and symptoms of
HBV relapse throughout their therapy and for several months following termination of therapy.

Dear Doctor Letter
In October 2005, Biogen Idec sent out a Dear Doctor letter to inform healthcare providers of new safety
information for AMEVIVE® (alefacept), which is now contraindicated for patients with HIV disease. This
decision is based on the pathophysiology of HIV and the fact that AMEVIVE® reduces CD4+ T lymphocyte
counts. Such a reduction could accelerate disease progression or increase complications of disease in these

Cleansing Agents
In a study by Retroscreen Virology, a subsidiary of University of London’s Queen Mary School of Medicine,
Skinvisible’s patent-pending Chlorhexidine Hand Sanitizer demonstrated a >99% kill on the “bird flu virus”
(H5N1) within seconds of contact. In vitro studies demonstrate a sustained release of the active ingredient
over a 6 hour period. The results were presented at the Retroscreen Virology Conference, “Bird Flu: The First
Pandemic of the 21st Century” in January 2006.