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Volume 4 • Number 3 • March 1999
Contents: (Full text available in print edition.)

Drug Treatments Introduced in 1998

Of 39 new drugs that gained regulatory approval in 1998, only three (Miglitol, Diastabol ® , Bayer-Sanofi; Mizolastine, Mizolen ® , Synthélabo - Galderma; thalidomide, Thalidomid ® , Celgene) were granted dermatological indications.1 Late in 1998, as a therapeutic group, when ranked by the number of active research and development projects, dermatologicals ranked 13 out of 17 2 , and when ranked by global sales, dermatological drugs were well down the list in 8th position out of 16. 3 Although there has been no noticeable reduction in the incidence of skin disease, there have been signs that a number of major pharmaceutical companies have a diminished interest in pursuing new drugs to treat skin disease. Perhaps reallocation of resources may be part of the reason why so few new drugs for skin diseases were introduced in 1998.
Dr. Stuart Maddin, Editor


  1. Scrip Magazine, Jan. 1999; 63.
  2. Phamaprojects, 1998
  3. IMS Health, 1998


Indication Generic/Trade®/Company Names Approval Date
Anti-acne Adapalene solution 0.1%
Differin ®
Canada 1995
USA 1998
  Tretinoin gel 0.25%
Avita ®
Canada 1997
USA 1998
for moderate acne plus contraceptive use Norgestimate / ethinyl estradiol
Ortho Tri-cyclen ®
Johnson & Johnson
USA 1996
Canada 1998
for moderate to severe acne non-responsive to other treatments Cyproterone acetate/ ethinyl estradiol
Diane 35 ®
Canada 1998
for secondarily infected skin lesions.
Mupirocin calcium cream 2%
Bactroban Cream ®
SmithKline Beecham
USA 1997
Canada 1998
Uses include some complicated skin and skin structure infections. Trovafloxacin (oral), Alatrofloxacin (IV)
Trovan ®
USA 1998
for the treatment of T. versicolor
Oxiconazole nitrate
Oxizole ® Stiefel
Oxistat ® Glaxo Wellcome
Canada 1998
USA 1997
recurrent herpes simplex in HIV patients*; suppression of genital herpes in immunocompromised patients; herpes zoster.
Famvir ®
SmithKline Beecham
USA 1997,
supplemental indication for neonatal patients Acyclovir sodium
Zovirax ®
Glaxo Wellcome
USA 1998
for genital and peri-anal warts
Aldara ®
3M Pharmaceuticals
Europe 1998
Diastabol ®
Bayer - distributed by Sanofi
USA 1997
USA 1998
Cutaneous T-cell Lymphoma
orphan drug status
Denileukin diftitox
Ontak ®
Seragen / Ligand Pharmaceuticals
Diabetic ulcer Becaplermin gel 0.01%
Regranex ®
Ortho McNeil
Canada 1998
Erythema nodosum leprosum Thalidomide
Thalidomid ®
USA 1998
HIV Abacavir
Ziagen ®
Glaxo Wellcome
USA 1998
Sustiva ®
DuPont Pharmaceuticals
USA 1998
Viramune ®
Boehringer Ingelheim
USA 1998
(combination formulation reduces the number of tablets required daily) Zidovudine 300 mg / lamivudine 150 mg
Glaxo Wellcome
Europe 1998
USA 1997
Kaposi’s sarcoma
newly encapsulated formulation
Caelyx ®
Schering Canada
Canada 1998
Lyme disease Lyme disease vaccine
LYMErix ®
SmithKline Beecham
USA 1998
Male pattern hair loss Finasteride 1 mg tab
Propecia ®
Canada 1998
USA 1997
Pain relief – topical Lidocaine / prilocaine cream patch
Emla ®
Canada 1998
USA 1998
first generic cyclosporin
Cyclosporine liquid
Sang Cya®
USA 1998
in children aged two years and older with mild to moderate psoriasis Calcipotriol
Dovonex ®
Canada 1998
new dosage formulation.
Metronidazole 0.75%
Metro-lotion ®
USA 1998
Skin augmentation Polymethylmethacrylate
Artecoll ®
Canada 1998
Skin substitute Graftskin
Apligraf ®
Canada 1997
USA 1998
chronic idiopathic in children 2–5 years
New dosage formulation.
Zyrtec ®
USA 1998
Mizolen ®
Synthélabo co-marketed with Galderma
Germany 1998
UV induced skin discoloration
New dosage combination.
Hydroquinone 4% / glycolic acid / antioxidant complex
Lustra ® (Viquin Forte ® in Canada)
Medicis Pharmaceutical
Canada 1998
USA 1998
Vulvar & vaginal atrophy
combined hormone replacement
Estradiol / norethindrone
Activelle ® (Estracomb ® patch in Canada)
Novo Nordisk
Canada 1998
USA 1998
Wound closure Topical tissue adhesive
Dermabond ®
Johnson & Johnson
USA 1998
Update on Drugs
Class Name/Company Approval Dates and Comments
Lyme disease Lyme disease vaccine
SmithKline Beecham
Approved by the US FDA for active immunization against Lyme disease in people aged 15-70. LYMErix® contains antigen from the only species of Borrelia burgdorferi found in the US. SmithKline Beecham are also developing a multivalent vaccine for use in Europe to combat several of the most common strains (B. burgdorferi, B afzeli and B. garinii) found there.
Varicella Vaccine Varicella Vaccine
Merck Frosst
Approved in Canada for use in children aged one year and older. This vaccine is already available in the US, Taiwan, Phillipines, Malaysia, Hong Kong and Brazil.

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EDITOR: Stuart Maddin ASSOCIATE EDITOR: David I. McLean INTERNET EDITOR: Harvey Lui PRINCIPAL MEDICAL WRITER: Rodger Hall MANUSCRIPT EDITOR: Rodger Hall  EDITORIAL ADVISORY BOARD: Kenneth A. Arndt, Beth Israel Hospital & Harvard Medical School, Boston; Wilma Fowler Bergfeld, Cleveland Clinic, Cleveland; Jan D. Bos, University of Amsterdam, Amsterdam; Enno Christophers, Universitäts-Hautklinik, Kiel; Hugo Degreef, Catholic University, Leuven; Richard L. Dobson, Medical University of South Carolina, Charleston; Boni E. Elewski, Case Western Reserve University, Cleveland; Barbara A. Gilchrest, Boston University School of Medicine, Boston; W. Andrew D. Griffiths, St. Johns Institute of Dermatology, London; Vincent C.Y. Ho, University of British Columbia, Vancouver; James J. Leyden, University of Pennsylvania, Philadelphia; Howard I. Maibach, University of California Hospital, San Francisco; Larry E. Millikan, Tulane University Medical Center, Louisiana; Takeji Nishikawa, Keio University School of Medicine, Tokyo; Constantin E. Orfanos, Freie Universitäts Berlin, Universitätsklinikum Benjamin Franklin, Berlin; Stephen L. Sacks, Viridae Clinic Sciences, Vancouver; Alan R. Shalita, SUNY Health Sciences Center, Brooklyn; Stephen K. Tyring, University of Texas Medical Branch, Galveston; John Voorhees, University of Michigan, Ann Arbor; Klaus Wolff, University of Vienna, Vienna
Skin Therapy Letter®. (ISSN 1201-5989) Copyright 1999 by International Skin Therapy Newsletter Inc. All rights reserved. Reproduction in whole or in part by any process in whole or in part is strictly forbidden without prior consent of the publisher in writing.
Published six times yearly by International Skin Therapy Newsletter Inc., 835 West Tenth Avenue, Vancouver, British Columbia, Canada V5Z 4E8. Tel: (604) 874-6112. Fax: (604) 873-9919. Annual subscription: Canadian $85 individual; $155 institutional (GST included). US $60 individual; $110 institutional. Outside North America: US$80 individual; $130 institutional. Quotes on multiple subscriptions and student rates supplied upon request.
Skin Therapy Letter Editor: Dr. Stuart Maddin Vol. 4 No. 3
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