Update on Drugs and Drug News - Number 12 2000

Antipsoriatic Agent

Etanercept
Enbrel®
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%
BenzaClin™
BenzaClin™

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 pharmacy.

Oral Contraceptive

Ethinylestradiol & Norethindrone Acetate
Estrostep
Pfizer

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.

Antihistamine

Desloratadine
Aerius™ & Neoclarityn™
Schering-Plough

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
Replagal™
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

Ciprofloxacin
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
Mentax®
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).

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.

Corticosteroids

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.