Drug Treatments for Skin Disease Introduced in 2001

Valganciclovir
Valcyte®
Hoffmann-LaRoche

Drug Class	Generic/Trade/Company Names	Indiction	Approving Regulatory Agency
Anti-acne Agents	Azelaic Acid Finevin® Cream 20% Berlex Laboratories	For the topical treatment of mild-to-moderate inflammatory acne.	US FDA
	Clindamycin 1%, Benzoyl Peroxide 5% BenzaClin™ Dermik Laboratories	Labeling change: the product can now be stored at room temperature for up to 2 months after at room temperature for up to 2 months after	US FDA
	US FDA Estrostep® Pfizer	Additional indication: for the treatment of moderate acne in women over 15 years of age.	US FDA
	Tazarotene Tazorac® 0.1% Allergan	For the treatment of acne vulgaris.	US FDA
	Tretinoin Gel Retin-A Micro Microsphere® AP Pharma/Johnson & Johnson Canada	For the treatment of acne vulgaris.	TPP – Canada
Antibacterial Agents	Cefuroxime, Dextrose for Injection Zinacef® GlaxoSmithKline	For the treatment of skin and skin structure infections, lower respiratory tract infections,urinary tract infections, lower respiratory tract infections,urinary tract infections,	US FDA
	Ciprofloxacin Geneva Pharmaceuticals	ANDA tentatively approved for this generic form of Bayer’s Cipro® for the treatment of urinary tract, skin and other infections.	US FDA
	Moxifloxacin HCl Avelox® Bayer	Additional indication: as a once daily treatment for uncomplicated skin and skin structure infections due to Staphylococcus aureus and Streptococcus pyogenes.	US FDA
Antifungal Agents	Caspofungin Acetate Cancidas® Merck	For the treatment of invasive aspergillosis in patients who do not respond to, or cannot tolerate other antifungal therapies.	US FDA
	Butenafine HCl Lotrimin Ultra® 1% Cream Schering-Plough	Switched to OTC for the topical treatment of symptomatic inflammatorytinea pedis, tinea cruris and tinea corporis due to Epidermophyton rubrum.	US FDA
	Butenafine HCl Mentax® 1% Cream Bertex Pharmaceuticals	Additional indication: for the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur, previously known as Pityrosporum orbiculare.	US FDA
	Clotrimazole, Betamethasone Dipropionate Cream Taro Pharmaceuticals	For the treatment of a variety of fungal conditions. It is bioequivalent to Schering-Plough’s Lotrisone® cream.	US FDA
Antihistamine	Desloratidine Aerius™ & Neoclarityn™ 5mg. tablets Schering-Plough	To be given once daily for the symptoms of chronic idiopathic urticaria in adults and children >12 years of age.	European Commission of the European Union
	Levocetirizine Xyzal®/Xusal® Sepracor	For the treatment of seasonal allergic rhinitis, perennial allergic rhinitis, and chronic idiopathic urticaria	German Regulatory Authorities
Antimetabolite Agents	Methotrexate Trexall® Barr Laboratories/DuPont Pharmaceuticals	For the treatment of neoplastic disease, psoriasis and rheumatoid arthritis. Trexall® represents new dosage strengths in 5, 7.5, 10, and 15mg tablets.	US FDA
Antipsoriatic Agents	Calcipotriol, Betamethasone Dipropionate Dovobet® Ointment Leo Pharma	For the treatment of psoriasis	TPP – Canada
Antiviral Agents	Varicella Zoster Immune Globulin VariZIG® Cangene	This product is a highly purified and specialized antibody against the varicella zoster virus that causes chicken pox.	TPP – Canada
	Valacyclovir HCl Valtrex® 500mg. caplets GlaxoSmithKline	A shorter course of therapy: the new 500mg. caplets can be prescribed as a 3-day course administered twice daily.	US FDA
Atopic Dermatitis	Pimecrolimus Elidel® Cream 1% Novartis Pharmaceuticals	For the treatment of mild-to-moderate atopic dermatitis in patients >2 years of age.	US FDA
Depigmenting Agents	Xtrac™ Excimer Laser System PhotoMedex	For the treatment of psoriasis and vitiligo.	US FDA
Enzyme Replacement Therapy	Recombinant Human Iduronidase (IDUA) Novazyme Pharmaceuticals	Granted Orphan Drug Status for the proprietary treatment of mucopolysaccharidosis I.	US FDA
	Agalsidase Alfa Replagal™ Transkaryotic Therapies (TKT)	For long-term treatment in patients with Fabry’s disease.	Norwegian Medicines Agency NZ’s Reg. Authority Iceland’s Regulatory Authority
	Agalsidase Beta Fabrazyme™ Genzyme	For the long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry’s disease.	European Commission of the European Union
Hair Growth	Eflornithine HCl Vaniqa® Cream 13.9% Westwood-Squibb	For the reduction of unwanted facial hair in women.	US FDA TPP - Canada
TPP - Canada	Amprenavir Agenerase® Glaxo Wellcome	Conditional Notice of Compliance: to be used with other antiretroviral agents for the treatment of HIV-1 infection.	TPP – Canada
	HIV Drug Resistance Test Trugene® HIV-1 Genotyping Test Visible Genetics	This test can identify which HIV medications have become ineffective because of the virus’ mutation in individual patients.	US FDA
	Tenofovir Disoproxil Fumerate Viread® Gilead Sciences	For the treatment of HIV infection when taken in combination with other antiretroviral agents	US FDA
	For the treatment of cytomegalovirus (CMV) retinitis in AIDS patients	US FDA
Hormonal Preparation	Transdermal 17-Beta Estradiol Estradot® Novartis Pharmaceuticals Canada	For the treatment of menopausal symptoms and for the prevention of postmenopausal osteoporosis.	Netherlands’ Regulatory Authority
Human Skin Construct	Biologically Active Dressing Composite Cultured Skin (CCS) ® Ortec International	For patients undergoing hand reconstruction to treat recessive dystrophic epidermolysis bullosa, a rare genetic disorder.	US FDA
Monoclonal Antibody	Infliximab Remicade® Centocor	For the treatment of severe, active and fistulizing Crohn’s Disease in adult patients who have not responded to conventional treatment	TPP – Canada
Mouth and Throat Product	Amlexanox Aptheal® 5% Paste Strakan Ltd.	For the treatment of aphthous ulcers.	UK MCA
Neurotoxins	Botulinum Toxin Type A BOTOX® Allergan	Additional indication: for the treatment of glabellar lines associated with corrugator and/or procerus muscle activity.	TPP – Canada
Oncologic Agents	Arsenic Trioxide Trisenox® Cell Therapeutics	Orphan drug designation given for the treatment of multiple myeloma and myelodysplastic syndromes.	European Commission of the European Union
Oral Contraceptive	Drospirenone/Ethinyl Estradiol Yasmin® Berlex Laboratories	Contains the progestin drospirenone, which exhibits antimineralocorticoid activity and influences water and electrolyte balance. Reduces sebum output.	US FDA
Photodynamic Therapy	Aminolevulinic Acid HCl Levulan® Kerastick™ Photodynamic Therapy Draxis Health/DUSA Pharmaceuticals	For the treatment of Actinic Keratosis of the face and scalp.	TPP – Canada
Sunscreens	Mequinol 2%, Tretinoin 0.01% Solagé® Topical Solution Westwood Squibb	For the treatment of solar lentigines and related hyperpigmented lesions.	TPP – Canada

In this issue:

1. Alternative Treatments For Atopic Dermatitis: A Selected Review
2. Drug Treatments for Skin Disease Introduced in 2001
3. Update on Drugs and Drug News - February 2002