Drug Treatments For Skin Disease Introduced in 2000

Drug Class	Generic/Trade/Company Names	Labelled Indication	Approving Regulatory Agency
Anti-acne Agent	Chloramphenicol, Sulphur, Hydrocortisone Acetate, 2-butoxyethyl Nicotinate, Allantoin Actinac Aventis Pharma	For the treatment of mild to moderate acne	TPP - Canada
	Clindamycin Phosphate & Benzoyl Peroxide Clindoxyl Gel Stiefel Canada	For the treatment of mild to moderate acne	TPP - Canada
	Clindamycin Phosphate Clindasol Cream 1% & Clindets Pledgets Stiefel Canada	For the treatment of mild to moderate acne	TPP – Canada
Antibacterial Agent	Levofloxacin Tablets/Injection Levaquin Tablets/Injection Ortho Pharmaceuticals	Additional indication for the treatment of complicated skin and skin structure infections at a higher dose of 750mg once daily	US FDA
	Linezolid Zyvox Pharmacia & Upjohn	For the treatment of complicated skin/skin structure infections, infections caused by vancomycin resistant Enterococcus, and hospital acquired pheumonia	US FDA
	Silver Sulfadiazine Flamazine Smith & Nephew	Previously available for superficial skin infections	TPP – Canada
Antifungal Agent	Amphotericin B Liposome for Injection Ambisome Fujisawa Canada	For the treatment of systemic or disseminated infections due to Candida, Aspergillus or Cryptococcus in patients refractory to, or intolerant of conventional amphotericin B therapy, or suffer renal impairment.	TPP – Canada
	Ciclopirox Olamine 1% Loprox Cream, Loprox Lotion Dermik Laboratories	For the treatment of fungal infections	TPP – Canada
	Ketoconazole 2% Cream Teva Pharmaceuticals	For the treatment of fungal infections	US FDA
	Terbinafine HCl 1% Solution Lamisil Novartis	For the treatment of interdigital athlete’s foot, jock itch and ringworm. Switched from prescription to OTC status	US FDA
	Terbinafine HCl Gen-Terbinafine 250mg Cap Genpharm	For the treatment of interdigital athlete’s foot, jock itch and ringworm. Switched from prescription to OTC status	TPP – Canada
	Terbinafine HCl Novo-Terbinafine 125- 250mg Cap Novopharm	For the treatment of interdigital athlete’s foot, jock itch and ringworm. Switched from prescription to OTC status	TPP – Canada
	Terbinafine HCl Terbinafine – 250 Pro Doc Limitée	For the treatment of fungal infections	TPP – Canada
Antihistamines	Loratadine Claritin Schering-Plough	For the treatment of chronic idiopathic urticaria and seasonal allergies in children ≥ 2 years of age	US FDA
Trimeprazine Tartrate Panectyl Aventis Pharma	Antipruritic	TPP – Canada
Antiinflammatory Agent	Amlexanox 5% Paste Apthera Access Pharmaceuticals	For the treatment of aphthous ulcers (canker sores)	TPP – Canada
Antipsoriatic Agent	Calcipotriol Dovonex Cream & Ointment Leo Pharma	New indication for the treatment of psoriasis, used in combination with topical corticosteroids, cyclosporin A, acitretin, and phototherapy (PUVA or UVB)	TPP – Canada
Antirejection Agent	Cyclosporin Gengraf Abbott Laboratories	For the prevention of organ rejections in kidney, liver and heart transplants. It is the bioequivalent to Neoral (Novartis Pharmaceuticals)	US FDA
Antirosacea Agent	Metronidazole Rosasol Topical Cream, 1% Stiefel	For the treatment of rosacea	TPP – Canada
Antiviral Agent	Docosanol Cream 10% Abreva Glaxo Smith Kline	For the treatment of recurrent oral facial herpes simplex infections	US FDA (OTC)
	Interferon-Alpha Veldona Amarillo Bioscience	For the treatment of papillomavirus warts in the oral cavity of HIV positive patients	US FDA (Orphan Drug Designation)
Corticosteroids	Flumethasone Pivalate PMS-FLUMETHASONECLIOQUINOL Pharmascience	For the treatment of otitis externa, and otomycosis due to aspergillus niger. It is the generic form of Locacorten Vioform (Novartis)	TPP – Canada
	Prednicarbate 0.1% Dermatop Emollient Cream & Dermatop Ointment Dermik Laboratories	For the relief of the inflammatory and pruritic manifestations of acute and chronic corticosteroidresponsive dermatoses	TPP – Canada
Dermatosclerosis Agent	Halofuginone Collgard Biopharmaceuticals	For the treatment of scleroderma	US FDA (Orphan Drug Designation)
HIV/AIDS	Amprenavir Agenerase Glaxo Wellcome	For use in combination with other anti-retroviral agents for the treatment of PI-experienced HIV infected adults and children ≥ 4 years of age	CPMP – Europe
	Lamivudine, Zidovudine & Abacavir Trizivir Glaxo Wellcome	For the treatment of HIV infection	US FDA
Hormonal Preparations	Testosterone Gel AndroGel 1% Unimed Pharmaceuticals	For the treatment of low testosterone levels linked with reduced sex drive/impotence, reduced lean body mass, reduced bone density, and lowered mood/energy levels in men who have not had breast or prostate cancer.	US FDA
Immunomodulators	Tacrolimus Ointment Protopic Fujisawa	For the treatment of moderate-to-severe atopic dermatitis or eczema	US FDA
Keratolytic Agent	Diclofenac Sodium Solaraze (US) Solarase (Canada) SkyePharma PLC	For the treatment of actinic keratosis	US FDA TPP – Canada
	5-fluorouracil Microsponge Solex Advanced Polymer Systems / Dermik Laboratories	For the treatment of actinic keratoses	US FDA
Neurotoxin	Botulinum Toxin Type B Myobloc Elan Corporation	Elan Corporation	US FDA
Oncologic Agent	Alitretinoin 0.1% Gel Panretin Ligand Pharmaceuticals	For the treatment of cutaneous lesions from AIDSrelated Kaposi’s sarcoma.	CPMP – Europe
	Bexarotene Capsules Targretin Ligand Pharmaceuticals	For the treatment of all stages of cutaneous T-cell lymphoma in patients who are refractory to > 1 prior systemic therapy.	US FDA
	Bexarotene 1% Gel Targretin Ligand Pharmaceuticals	For the treatment of cutaneous lesions in patients with early-stage cutaneous T-cell lymphoma who cannot tolerate other therapies.	US FDA
	Bleomycin Gensia Sicor Pharmaceuticals	This generic injection form of Bristol-Myers Squibb’s bleomycin (Blenoxane) tentatively approved for the management of squamous cell carcinoma, lymphomas and testicular carcinoma	US FDA
	Cyclophosphamide 25mg and 50mg Tablets Roxane Laboratories	For treatment of certain forms of cancer to be used in combination with other antineoplastic therapies	US FDA
	Hydroxyurea Barr Laboratories	This generic formulation approved for use in the treatment of melanoma	US FDA
	Paclitaxel Paxene IVAX/Bristol-Myers Squibb	For the treatment of AIDS-related Kaposi’s sarcoma in patients who have failed prior liposomal anthracycline therapy.	TPP – Canada
Pediculocides	Piperonyl Butoxide/Pyrethrins Rid Mousse Soltec Research	For the treatment of head, pubic (crab), and body lice	US FDA
Photo-aging	Tretinoin Cream Renova 0.02% Ortho Pharmaceuticals	For reducing fine facial wrinkles associated with chronic sun exposure and the natural aging process.	US FDA
	Tretinoin Cream Renova 0.05% Renova 0.05%	For use in the mitigation of fine wrinkles, mottled hyperpigmentation and tactile roughness of facial skin	US FDA
Scalp Dermatoses	Clobetasol Propionate Olux Foam 0.05% Connetics	For the short-term topical treatment of inflammatory and pruritic manifestations of moderate-to-severe corticosteroid-responsive dermatoses of the scalp.	US FDA
Topical Anesthetic	Lidocaine & Procaine EMLA Cream & Patch AstraZeneca	Topical anesthetic for dermal analgesia	TPP - Canada
Transdermal Agent	Estradiol Transdermal System Vivelle Novogyne Pharmaceuticals	For the additional indication of postmenopausal osteoporosis for this transdermal estrogen patch	US FDA
Urticaria	Fexofenadine HCl Allegra Aventis Pharmaceuticals	For the additional treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children ≥ 6 years of age	US FDA
Vaginal Preparations	Butoconazole Nitrate Gynazole 2% Vaginal Cream KV Pharmaceuticals	For the treatment of vaginal yeast infections using only one dose.	US FDA
	Clotrimazole 2% Clotrimazole 2% Three Day Vaginal Cream Taro Pharmaceuticals	OTC for the treatment of vaginal yeast infections	US FDA
	Estradiol Vaginal Ring Estring Pharmacia and Upjohn	For the treatment of urogenital symptoms associated with post-menopausal vaginal atrophy	US FDA
Wound Care	Tissue Engineered Collagen Matrix Oasis Wound Dressing COOK’s	For the treatment of full-thickness skin injuries	US FDA
	Graftskin Apligraf Novartix Pharmaceuticals	For expanded use with conventional diabetic food ulcer care in the treatment of diabetic food ulcers > 3 weeks in duration	US FDA
	“Intelligent” Dressing Acemannan Hydrogel Carrington Laboratories	For the management of postsurgical incisions, firstand second-degree burns, arterial and venous stasis ulcers, pressure ulcers, and foot ulcers	US FDA

TPP: Health Canada, Ottawa – Therapeutic Products Program
FDA: United States Food and Drug Administration
CPMP: European Union’s Committee for Proprietary Medicinal Products

In this issue:

1. Oral Contraceptives in the Treatment of Acne
2. Drug Treatments For Skin Disease Introduced in 2000
3. Update on Drugs and Drug News - Number 5 2000