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 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

Indication	Generic / Trade® / Company Names	Approval 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

In this issue:

1. Drugs that may exacerbate psoriasis
2. Drug Treatments Introduced in 1998
3. Update on Drugs and Drug News - Number 3 1999