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% | Canada 1995 |
Tretinoin gel 0.25% | Canada 1997 | |
for moderate acne plus | Norgestimate / ethinyl estradiol | USA 1996 |
for moderate to severe acne nonresponsive | Cyproterone acetate/ ethinyl estradiol | Canada 1998 |
Antibacterial | Mupirocin calcium cream 2% | USA 1997 |
Uses include some complicated | Trovafloxacin (oral), Alatrofloxacin (IV) | USA 1998 |
Antifungal | Oxiconazole nitrate | Canada 1998 |
Antiherpes | Famciclovir | USA 1997, |
supplemental indication for | Acyclovir sodium | USA 1998 |
Anti-HPV for genital and peri-anal warts | Imiquimod | Europe 1998 |
Miglitol | USA 1998 | |
Cutaneous T-cell Lymphoma | Denileukin diftitox | USA APPROVAL |
Diabetic ulcer | Becaplermin gel 0.01% | Canada 1998 |
Erythema nodosum leprosum | Thalidomide | USA 1998 |
HIV | Abacavir | USA 1998 |
Efavirenz | USA 1998 | |
Nevirapine | USA 1998 | |
(combination formulation reduces | Zidovudine 300 mg / lamivudine 150 mg | Europe 1998 |
Kaposi’s sarcoma | Doxorubicin | Canada 1998 |
Lyme disease | Lyme disease vaccine | USA 1998 |
Male pattern hair loss | Finasteride 1 mg tab | Canada 1998 |
Pain relief – topical | Lidocaine / prilocaine cream patch | Canada 1998 |
Psoriasis | Cyclosporine liquid | USA 1998 |
in children aged two years and | Calcipotriol | Canada 1998 |
Rosacea | Metronidazole 0.75% | USA 1998 |
Skin augmentation | Polymethylmethacrylate | Canada 1998 |
Skin substitute | Graftskin | Canada 1997 |
Urticaria | Cetirizine | USA 1998 |
Mizolastine | Germany 1998 | |
UV induced skin discoloration | Hydroquinone 4% / glycolic acid / antioxidant complex | Canada 1998 |
Vulvar & vaginal atrophy | Estradiol / norethindrone | Canada 1998 |
References
- Scrip Magazine, Jan. 1999; 63.
- Phamaprojects, 1998
- IMS Health, 1998
