ClassName/CompanyApproval Dates and Comments

Antimicrobial Agent
Nanocrystalline Silver Cream
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
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.

Smallpox Vaccine
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.