|Name/Company||Approval Dates and Comments|
Spinosad 0.9% cream rinse
The US FDA approved a topical suspension of spinosad in January 2011 for the treatment of head lice in patients =4 years of age. Spinosad is a compound derived from a soil microbe and its mechanism of action includes excitation of neurons in the central nervous system, then hyperexcitation, and paralysis, leading to death of the insect. The product resolves most head lice infestations in about 10 minutes with one application, and nit combing is not required. It is available by prescription only and not approved for use in patients younger than 4 years of age. Exposure in children
Light emitting diode (LED) skin rejuvenation system
The US FDA granted clearance to market this esthetic device in January 2011 for skin rejuvenation. The product is approved for the treatment of wrinkles, rhytides, and fine lines in the periorbital (around the eye) area. Tanda™ Professional Rejuvenate red light home use device reduces the appearance of fine lines and wrinkles by stimulating collagen and elastin production, and enhancing skin hydration.
Health Canada granted screening acceptance to this novel, next generation oral calcineurin inhibitor in December 2010 for the treatment of moderate to severe psoriasis. In comparison to conventional systemic immunosuppressive compounds, voclosporin may offer comparable efficacy with fewer adverse effects.
A recently published retrospective study* explored the risk of herpes zoster infection (or shingles) after receiving the live, attenuated varicella zoster virus (VZV) vaccine (Zostavax®). The 75,761 patients in the vaccinated cohort were age matched (1:3) to 227,283 in the unvaccinated group. Study findings demonstrated vaccine efficacy in a large, immunocompetent, heterogeneous population consisting of men and women =60 years of age in general practice settings. Herpes zoster vaccine recipients were more likely to be white, female, with more outpatient visits, and had fewer chronic conditions. Investigators found a significant risk reduction of herpes zoster infection across all ages and subgroups (e.g., healthy subjects and individuals with chronic disorders, such as diabetes, kidney, heart, and lung diseases). Receiving the VZV vaccine was associated with about a 55% reduced risk of developing shingles.
The VZV vaccine was approved by the US FDA in 2006 and recommended for use in adults =60 years of age without contraindications by the Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention (CDC), in 2007. According to a recent study by the CDC, only 10% of adults =60 years of age reported receiving the shingles vaccination in 2009, a slight increase from 6.7% reported in 2008.
*Tseng HF, Smith N, Harpaz R, Bialek SR, Sy LS, Jacobsen SJ. Herpes zoster vaccine in older adults and the risk of subsequent herpes zoster disease. JAMA 305(2):160-6 (2011 Jan 12).