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Update on Drugs and Drug News - Number 3 1997


Class Name/Company Approval Dates and Comments

Antibiotic

Mupirocin calcium cream 2%
Bactroban Cream®
SmithKline Beecham

Approved by the US FDA December, 1997 for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of Staphylococcus aureus and Streptococcus pyogenes.

Antifungal

Butenafine cream
Mentax®
Penederm

A supplemental claim of efficacy for a one week course for interdigital tinea pedis was granted by the US FDA November, 1997.

Diabetic ulcers

Becaplermin gel 0.01%
Regranex®
Ortho-McNeil

Approved by the US FDA December, 1997 for the treatment of diabetic foot ulcers. Becaplermin is a genetically engineered, platelet derived growth factor. It is produced by recombinant technology in yeast cells and is not derived from blood.

Male-pattern hair-loss

Finasteride 1mg tablets
Propecia®
Merck

Approved by the US FDA December, 1997 for the treatment of male-pattern hair-loss. It will only be available on prescription and is for use by men only. Finasteride has already been approved in New Zealand and Mexico.

Minoxidil 5%
Rogaine Extra Strength for Men®
Pharmacia & Upjohn

Approved by the US FDA December, 1997 for the OTC treatment of male-pattern baldness.


Drug News

Skin - Artificial

Dermagraft®
Advanced Tissue Science

The FDAs Advisory Committee has recommended approval for the treatment of diabetic foot ulcers.

Graftskin® (apligraf)
Novartis

The FDAs Advisory Committee has recommended approval for the treatment of venous leg ulcers. (Reviewed in Vol. 2 No. 5)

Ultraviolet light

An advisory group to the FDA recommended that ultraviolet light, whether from sunlight or an artificial light source such as tanning booths and tanning beds, be listed as known to be a human carcinogen. Up to 10% of Americans, mostly young women, were estimated to have used artificial tanning devices. The largest occupational exposure to ultraviolet light is in the estimated half million welders using electric arc welding equipment.


In this issue:

  1. Thalidomide
  2. Rosacea
  3. Update on Drugs and Drug News - Number 3 1997