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Written for dermatologists by dermatologists. Indexed by the US National Library of Medicine.
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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