image of silk fabric and dry skin

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 172, 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

IndicationGeneric / Trade® / Company NamesApproval Date

Anti-acne

Adapalene solution 0.1%
Differin®
Galderma

Canada 1995
USA 1998

Tretinoin gel 0.25%
Avita®
Penederm

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 nonresponsive
to other treatments

Cyproterone acetate/ ethinyl estradiol
Diane 35®
Berlex

Canada 1998

Antibacterial
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®
Pfizer

USA 1998

Antifungal
for the treatment of T. versicolor

Oxiconazole nitrate
Oxizole® Stiefel
Oxistat® Glaxo Wellcome

Canada 1998
USA 1997

Antiherpes
recurrent herpes simplex in HIV
patients*; suppression of genital
herpes in immunocompromised
patients; herpes zoster.

Famciclovir
Famvir®
SmithKline Beecham

USA 1997,
1998*

supplemental indication for
neonatal patients

Acyclovir sodium
Zovirax®
Glaxo Wellcome

USA 1998

Anti-HPV

for genital and peri-anal warts

Imiquimod
Aldara®
3M Pharmaceuticals

Europe 1998
USA 1997

Miglitol
Diastabol®
Bayer – distributed by Sanofi

USA 1998

Cutaneous T-cell Lymphoma
orphan drug status

Denileukin diftitox
Ontak®
Seragen / Ligand Pharmaceuticals

USA APPROVAL
RECOMMENDED

Diabetic ulcer

Becaplermin gel 0.01%
Regranex®
Ortho McNeil

Canada 1998

Erythema nodosum leprosum

Thalidomide
Thalidomid®
Celgene

USA 1998

HIV

Abacavir
Ziagen®
Glaxo Wellcome

USA 1998

Efavirenz
Sustiva®
DuPont Pharmaceuticals

USA 1998

Nevirapine
Viramune®
Boehringer Ingelheim

USA 1998

(combination formulation reduces
the number of tablets required
daily)

Zidovudine 300 mg / lamivudine 150 mg
Combivir®
Glaxo Wellcome

Europe 1998
USA 1997

Kaposi’s sarcoma
newly encapsulated formulation

Doxorubicin
Caelyx®
Schering Canada

Canada 1998

Lyme disease

Lyme disease vaccine
LYMErix®
SmithKline Beecham

USA 1998

Male pattern hair loss

Finasteride 1 mg tab
Propecia®
Merck

Canada 1998
USA 1997

Pain relief – topical

Lidocaine / prilocaine cream patch
Emla®
Astra

Canada 1998
USA 1998

Psoriasis
first generic cyclosporin

Cyclosporine liquid
Sang Cya®
SangStat

USA 1998

in children aged two years and
older with mild to moderate
psoriasis

Calcipotriol
Dovonex®
Leo

Canada 1998

Rosacea
new dosage formulation.

Metronidazole 0.75%
Metro-lotion®
Galderma

USA 1998

Skin augmentation

Polymethylmethacrylate
Artecoll®
Canderm

Canada 1998

Skin substitute

Graftskin
Apligraf®
Novartis

Canada 1997
USA 1998

Urticaria
chronic idiopathic in children 2–5 years
New dosage formulation.

Cetirizine
Zyrtec®
Pfizer

USA 1998

Mizolastine
Mizolen®
Synthélabo comarketed with Galderma

Germany 1998

UV induced skin discoloration
New dosage combination.

Hydroquinone 4% / glycolic acid / antioxidant complex
Lustra® (Viquin Forte® in Canada) Medicis Pharmaceutical
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

References

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