| Class | Name/Company | Approval Dates and Comments |
| Medical Device | Clinical Phototherapy System ClearTouch™ Light Unit Assembly Radiancy |
The US FDA granted marketing approval in December 2004, for this light-based therapy for the treatment of pustular inflammatory acne. |
| Antiarthritic Agent | Adalimumab HUMIRA® 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 Agent | Dalbavancin VicuronPharmaceuticals |
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 Agent | MDX-010
Medarex |
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 Agent | Clindamycin Evoclin® Foam 1% Connetics |
The US FDA approved this antibiotic foam in October 2004, for the treatment of acne vulgaris. Evoclin® was formerly referred to as Actiza™. |
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Drug News |
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| Drug Warning | The 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. | |
