ClassName/CompanyApproval Dates and Comments

Antibacterial Agent
Retapamulin Ointment 1%
The US FDA approved this antibacterial in April 2007 for the topical treatment of impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes, the two most common types of bacteria implicated in this kind of infection. This product is the first in a new class of prescription topical antibacterials to be used twice daily for a 5 day period in patients under 9 months of age.

Quadrivalent Human Papillomavirus Recombinant Vaccine
The US FDA received a supplemental Biologics License Application in April 2007 for this cervical cancer vaccine. The updated labeling will include efficacy data showing some protection against additional HPV types responsible for >10% of cervical cancers. Efficacy data indicates protection against additional vaginal and vulvar cancers and data on immune memory. This vaccine is approved for use in girls and women ages 9-26 for the prevention of HPV types 16- and 18-related cervical cancers, cervical precancers (CIN 2/3 and AIS), vulvar precancers (VIN 2/3) and vaginal precancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18.

Quadrivalent Human Papillomavirus Recombinant Vaccine
The European Commission approved two new formulations of this antihistamine in April 2007: orodispersible tablets for the treatment of symptoms associated with allergic rhinitis and chronic idiopathic urticaria (CIU) in adults and children >6 years of age; and oral solution for the treatment of symptoms associated with allergic rhinitis and CIU in adults and children >1 year of age.

Drug News

Health Insurance Coverage for Laser System
PhotoMedex announced in March 2007 that the Blue Cross Blue Shield Association revised the portion of its National Reference Policy in the US to now include the PhotoMedex® XTRAC® Laser System’s treatment for psoriasis. The policy now states that the XTRAC® Laser may be considered medically necessary for the treatment of mild-to-moderate psoriasis that is unresponsive to conservative treatment, and further states that the XTRAC® laser may be considered medically necessary for the treatment of moderate-to-severe psoriasis comprising less than 20% of body surface area.

Effects of Caffeine on Methotrexate
In an article recently published in the International Journal of Dermatology*, Swanson and colleagues reported that, based on animal and human studies, the therapeutic benefit of methotrexate in the treatment of rheumatoid arthritis may be substantially reduced in patients who are concomitantly consuming caffeine. The authors further concluded that their results did not rule out an effect of caffeine in other inflammatory diseases treated with methotrexate.
*Swanson DL, et al. Int J Dermatol 46(2):157-9 (2007 Feb).