UPDATE ON DRUGS | ||
| Class | Name/Company | Approval Dates and Comments |
Antimicrobial Agent | Nanocrystalline Silver Cream NPI32101 NUCRYST Pharmaceuticals | The US FDA approved this prescription topical cream in July 2007. NPI32101 is a patent protected nanocrystalline silver compound that acts as a broad spectrum antimicrobial barrier to organisms including strains resistant to MRSA, such as Pseudomonas aeruginosa and Staphylococcus aureus. |
Antibacterial Agent | Daptomycin for Injection CUBICIN® Cubist Pharmaceuticals | The EMEA approved this IV antibiotic at 6mg/kg in September 2007 for the additional indications of right-sided infective endocarditis (RIE) due to Staphylococcus aureus, and Staphylococcus aureus bacteremia, when associated with RIE or with complicated skin and soft-tissue infections. |
Hand Eczema | Oral Alitretinoin BAL4079Basilea Pharmaceutica | The EMEA received a Marketing Authorization Application in September 2007 for this investigational drug for the treatment of severe refractory chronic hand eczema. |
Vaccine | Smallpox Vaccine ACAM2000 Acambis PLC | The US FDA licensed a new vaccine in August 2007 to protect against smallpox. This vaccine is intended for the inoculation of people at high risk of exposure to smallpox and could be used to protect individuals and populations during a bioterrorist attack. It will be included in the Center for Disease Control and Prevention’s Strategic National Stockpile of medical supplies. |
Drug News | |
Oncologic Agents | According to a study published in a recent issue of Clinical Cancer Research, the appearance of a rash in cancer patients treated with erlotinib (Tarceva®, Genentech) is strongly associated with longer survival. For patients taking this drug who developed a moderate-to-severe rash, survival without progression of disease was 245% longer than in patients who had a mild rash or none at all. These rashes can be controlled with mild steroids or antibiotics, and in most cases, they will improve with treatment. *Wacker B, et al. Clin Cancer Res 13(13):3913-21 (2007 Jul). |
US FDA Regulations | In August 2007, the US FDA proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter sunscreen products. This proposed regulation creates a consumer-friendly rating system designed to easily identify both levels of UVB and UVA protection offered by a product. Additional recommendations include the amended definition of SPF from “sun protection factor” to “sunburn protection factor”, which is intended to contain consumer notions of adequate sun protection. A new expanded ratings system for UVA sunscreen products will use a scale of one to four stars. One star = low UVA protection, two stars = medium protection, three stars = high protection, and four stars = the highest protection available. If a sunscreen does not provide at least a low level of protection, the FDA is proposing that it must bear a “no UVA protection” mark on the front label near the SPF value. Ratings would be derived from two tests proposed to assess the effectiveness of sunscreens: the first measures a product’s ability to reduce the amount of UVA radiation that passes through it; the second measures its ability to prevent tanning. When finalized, this regulation would amend the existing OTC sunscreen rule published in 1999. Additionally, the proposed rule would revise the existing SPF testing procedures and allow for new combinations of active ingredients. The FDA is asking for public comments on this initiative, and is accepting comments until November 26, 2007. To submit comments go to: www.fda.gov/dockets/ecomments. |
