ClassName/CompanyApproval Dates and Comments

Antifungal Agent
Terbinafine hydrochloride
Novartis Pharmaceuticals
The US FDA approved this antifungal agent in September 2007
for the treatment of tinea capitis in young children .4 years of
age. The new granular formulation, which can be sprinkled on
childrenfs food, is intended to improve patient compliance and
treatment outcomes. The recommended dosage is based on the
childfs weight and administered once daily for 6 weeks.

Antiviral Agent

TEVA Pharmaceutical Industries
The US FDA approved the first generic formulation of famciclovir
(comparable brand, Famvir®, Novartis) in August 2007 for the
treatment of herpes zoster (shingles).

BAL5788Basilea Pharmaceutica/
Health Canada accepted a Review New Drug Submission for
this antibacterial agent in September 2007 for the treatment
of complicated skin and skin structure infections, including
diabetic foot infections. Ceftobiprole is a novel broad-spectrum
cephalosporin antibiotic effective against drug-resistant bacteria.

Drug News

Antipsoriatic Agent
During the recent World Congress of Dermatology meeting, lead investigator, Craig Leonardi,
presented data from an international multicenter, randomized, double-blind placebo-controlled
Phase III study, which showed that two-thirds of the subjects treated with the injectable medication,
ustekinumab (CNTO 1275, Centocor/ Johnson & Johnson), experienced marked improvement in their
psoriasis when compared with placebo. Ustekinumab is a novel fully-humanized monoclonal antibody
that targets interleukin-12 and interleukin-23. These proteins are believed to play an integral role in
immune-mediated inflammatory diseases, such as psoriasis. Over 1,200 patients with moderate-tosevere
psoriasis were randomized to one of three treatment arms: one of two different doses of the
study drug, or placebo. At week-12, as measured by the PASI, 76% of patients who were administered
the higher dose, and 67% of those who received the lower dose, achieved at least 75% improvement in
their symptoms, compared with only 4% in those who received placebo. Furthermore, approximately
50% of the subjects who were treated with the higher dose of the study medication experienced
clearing of almost all psoriatic lesions, and exhibited substantial improvement in other associated
symptoms, as compared with only 1% of the placebo group.
Leonardi C, et al. CNTO 1275 (anti-Il-12/23p40) Treatment of psoriasis: phase 3 trial results. At the
21st meeting of the World Congress of Dermatology (October 1-5, 2007) Buenos Aires, Agrentina;
Book 1, Abstract 1543.

In September 2007, the US FDA has gained additional powers following the passage of a bill by
the US Senate. The new legislation will enable the US FDA to require new warnings on approved
prescription drugs if warranted; mandate the completion of post-approval studies; or limit its
distribution in cases where concerns arise regarding a product’s safety. Fines for up to $10 million can
be imposed for noncompliance. These changes were proposed in response to the recent controversial
delayed handling by the US FDA of potentially severe or life-threatening side-effects that were linked
to certain prescription medications. The new regulations are intended to improve postmarketing
surveillance programs and place emphasis on long-term patient safety. Pharmaceutical companies will
be required to announce results from clinical studies of marketed products in a public database. More
information on the US FDA’s Drug Safety Initiative can be found at: