ClassName/CompanyApproval Dates and Comments

Antipsoriatic Agent



Immunex/Wyeth-Ayerst Laboratories

The US FDA gave priority review status to this tumor-necrosis-factor
inhibitor in October 2001, for the treatment of psoriatic arthritis. No
other product indicated for the treatment of the signs and symptoms
of psoriatic arthritis has ever been reviewed by the US FDA.

Antibacterial Agent

Clindamycin 1%, Benzoyl Peroxide 5%



The US FDA approved a labeling change in September 2001, for
this combination acne treatment. This product can be stored at room
temperature for up to two months after being dispensed by a

Oral Contraceptive

Ethinylestradiol & Norethindrone Acetate



The US FDA approved an additional indication for this oral
contraceptive in July 2001, to treat moderate acne in women over
15 years of age.



Aerius™ & Neoclarityn™


The European Commission of the European Union granted marketing
authorization in August 2001, for these 5mg tablets to be given once
daily as a nonsedating treatment for the symptoms of chronic
idiopathic urticaria in adults and children 12 years of age and older.

Enzyme Replacement Therapy

Agalsidase Alfa


Transkaryotic Therapies (TKT)

The Norwegian Medicines Agency granted marketing authorization
in August 2001, to this enzyme replacement therapy for long-term
treatment in patients with Fabry Disease. In October 2001, New
Zealand and Iceland also granted marketing approval. It has now
been approved in 18 countries worldwide.

Antibacterial Agent


Geneva Pharmaceuticals

The US FDA tentatively approved an ANDA in August 2001, for
this generic form of Bayer’s Cipro®. It is indicated for treating
urinary tract, skin, and other infections.

Antifungal Agent

Butenafine HCl


Bertek Pharmaceuticals

The US FDA approved a new indication in August 2001, for this
antifungal agent. It is now indicated for the treatment of tinea
(pityriasis) versicolor caused by Malassezia furfur (formerly
Pityrosproum orbiculare).

Drug News

Public Health Advisory

The US FDA is approving new labeling for the use of several antibiotics to treat anthrax. The use of this and
additional information concerning dosing regimens of doxycycline and other antibiotics will be provided.
Doxycycline is approved for the treatment of cutaneous and inhalation anthrax after exposure.

Anti-acne Agent

Pilot Therapeutics signed an agreement with Bristol-Myers Squibb (BMS) giving Pilot exclusive, worldwide
license to develop and market a class of oral retinoids patented by BMS. Pilot will initially develop the drugs
as a treatment for severe acne and may also develop them as a cancer treatment. It will pursue development
up to Phase IIa trials and will seek a partner for late-stage development, FDA approval and marketing.


Connetics Corporation announced in October 2001, that it has made available 50gm cans of its topical
corticosteroid foams: Luxiq® 0.12% (betamethasone valerate) and Olux® 0.05% (clobetasol propionate).
These foams deliver treatment to affected areas through a novel foam vehicle and are indicated for the topical
treatment of inflammatory and pruritic manifestations of corticosteroid responsive scalp dermatoses.