ClassName/CompanyApproval Dates and Comments
Medical DeviceClinical Phototherapy

ClearTouch™ Light Unit

The US FDA granted marketing approval in December
2004, for this light-based therapy for the treatment of
pustular inflammatory acne.
Antiarthritic AgentAdalimumab
Abbott Laboratories
The US FDA received a supplemental Biologics License
Application in December 2004, for the additional
indication of psoriatic arthritis. Also in December 2004,
the EMEA received a Marketing Authorization Application
for this human monoclonal antibody for the same
additional indication. It is currently approved in the US
and the European Union for the treatment of rheumatoid
arthritis in adult patients when the response to diseasemodifying
antirheumatic drugs has been inadequate.
Antibacterial AgentDalbavancin
The US FDA received a New Drug Application in
December 2004, for this novel antibiotic for the treatment
of complicated skin and soft tissue infections caused
by Gram-positive bacteria, including the most difficultto-
treat strains of Staphylococcus-methicillin-resistant
Staphylococcus aureus.
Oncologic AgentMDX-010


The US FDA granted Fast Track Designation in October
2004, for this fully human antibody in combination with
MDX-1379, a melanoma vaccine, for the treatment of
previously treated, unresectable Stage III and Stage IV
metastatic melanoma.
Oncologic AgentClindamycin
Evoclin® Foam 1%
The US FDA approved this antibiotic foam in October
2004, for the treatment of acne vulgaris. Evoclin® was
formerly referred to as Actiza™.

Drug News

Drug WarningThe US FDA issued a public health advisory directing health care providers to prescribe pimecrolimus (Elidel©, Novartis) and tacrolimus (Protopic©, Fujisawa) only as directed and only after other eczema treatments have failed to work because of a potential cancer risk associated with their use. In addition, they added a black box warning to the health professional label for both products and are developing a Medication Guide for patients. The move was based on animal studies that have shown that three different species of animals have developed cancer following exposure to these drugs applied topically or orally and at doses higher than generally used by patients. The risk of cancer appeared to be dose-dependent increasing with increasing drug dose and duration. The products’ manufacturers have agreed to conduct research to determine whether there is an actual risk of cancer in humans, and if so, its extent. The President of the American Academy of Dermatology, Dr. Clay J. Cockerell, stated that they are very disappointed that the US FDA has taken this action, despite the fact that there is no data that proves proper topical use of these products is dangerous in humans.