Class Name/Company Approval Dates and Comments

Antifungal Agent


Caspofungin Acetate


Cancidas

Merck

The US FDA approved this antifungal agent in January 2001, for the
treatment of invasive aspergillosis in patients who do not respond to
or cannot tolerate other antifungal therapies. It is in a new class of
antifungals called echinocandins or glucan synthesis inhibitors, and
the first to be approved by the FDA.

Hair Growth


5% Minoxidil Topical
Solution

Alpharma

The US FDA approved this generic version of Rogaine (Pharmacia),
in November 2000, for the treatment of thinning hair or hair loss in
men.

Sunscreens


Mequinol 2%, Tretinoin 0.1%


Solagé Topical Solution

Westwood Squibb

TPP – Canada approved this topical agent in January 2001, for the
treatment of solar lentigines and related hyperpigmented lesions.

Human Skin
Construct


Biologically Active Dressing


Composite Cultured Skin (CCS)

Ortec International

The US FDA approved this human skin construct in February 2001,
for patients undergoing hand reconstruction to treat recessive
dystrophic epidermolysis bullosa, a rare genetic disorder. CCS was
approved under the Humanitarian Device Exemption Program,
which is reserved for devices that treat diseases affecting less than
4000 people in the US.

Depigmenting
Agents

Xtrac Excimer Laser System

PhotoMedex

The US FDA approved an additional indication for this system in
February 2001, for the treatment of vitiligo. It was originally
approved in January 2001, for the treatment of psoriasis. This system
uses UVB radiation and offers an alternative to PUVA, the most
popular therapy for vitiligo.


Drug News

Drug Warning

The US FDA is advising manufacturers of vaginal creams and suppositories containing miconazole to add a
new warning on product labels advising women who take warfarin (an anticoagulant) to check with their
doctor for advice before using these OTC products. The FDA has received reports of women who
experienced problems with blood clotting when taking the two drugs simultaneously. Physicians and patients
should be aware that patients who need to use both these drugs at the same time should be monitored.

Antiviral Agent

Abreva (docosanol 10% cream was launched by SmithKline Beecham (licensed from Avanir
Pharmaceuticals) in the US as an OTC treatment for recurrent oral-facial herpes infections.

Anti-acne Agent

Dermik Laboratories launched its new combination acne therapy, BenzaClin Topical Gel (clindamycin 1%
and benzoyl peroxide 5%) in February 2001. In clinical studies this drug was shown to be significantly
more effective that either clindamycin or benzoyl peroxide alone in treating acne. BenzaClin is now
available by prescription in the US.

Neurotoxin

Athena Neurosciences, a division of Elan Pharma launched NeuroBloc (botulinum toxin type B) in the UK
in February 2001. It is the first treatment for cervical dystonia that contains the type B form of this
neurotoxin.