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Update on Drugs and Drug News - Number 1 1998


Class Name/Company Approval Dates and Comments

Antipsoriatic

Cyclosporine solution & capsules
Neoral®
Novartis

Approved by the FDA June 19, 1997 for the treatment of severe recalcitrant psoriasis. Already approved in Canada and Europe. The previous formulation is being withdrawn.

Actinic keratosis

Diclofenac gel 3%
Solarase®
Hyal

British regulatory authorities have given conditional acceptance for the treatment of actinic keratosis. Hyal is presently awaiting approval for this indication in a number of other countries.

Artificial skin

Dermagraft®
Smith & Nephew

Approved by the HPB in Canada August, 1997 as a human dermal replacement for the treatment of diabetic foot ulcers.

Laser system

Er,Cr:Y laser system
Dermalase system®
Biolase Technology

Approved by the FDA July, 1997. This laser system utilizes an air-water spray to cool the tissues during dermatologic and general surgical procedures.

Scars

Silicon based device
SKAR CARE
Life Medical Sciences

Approved by the FDA August, 1997 as an externally worn device for the management of hypertrophic & keloid scars.


Class Name/Company Clinical Trial Outcome

Male hair loss

Finasteride 1 mg
Propecia®
Merck

Results from an international Phase III, double-blind, placebo controlled trial found that finasteride stopped hair loss in 86% of the men treated and led to hair growth in half those treated. Loss of libido was reported in 1.8% of men.


Class Name/Company New Formulation

Anti-acne

Adapalene cream 0.1%
Differin®
Galderma Canada

This cream formulation was recently approved by the Canadian HPB for the topical treatment of acne. Gel and solution (both 0.1%) were approved by the FDA April, 1996. Adapalene is also approved in many other countries.


Class Name/Company Drug Warning

Antiseborrheic

Zinc pyrithione
Skin-Cap®
Cheminova

Some assays detect potent steroids (see Page 1). The FDA have issued a Stop & Detain order on all shipments and have been warning users, including psoriatics, of potential side effects.


In this issue:

  1. The Skin-Cap® Story
  2. Photodynamic Therapy (PDT) in Dermatology: Sooner or Later?
  3. Update on Drugs and Drug News - Number 1 1998