|
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.
|