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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

Roche Introduces New Drug Warnings for Accutane in US

As a result of recent meetings held by the US FDA, Roche has introduced further steps to inform doctors and patients about possible side effects by their anti-acne drug Accutane (isotretinoin), such as birth defects, mental disorders and suicide.

Doctors must now make sure their patients sign a consent form that explains the drug’s possible risks before they can write the prescription for this drug. As well, each prescription for Accutane will include a consumer-friendly pamphlet that details the benefits and the possible side effects.

Accutane labelling already includes both birth defects and mental disorders. Roche has taken several steps to publicize the drug’s potential teratogenic effects, including an elaborate pregnancy prevention program, as well as a tracking program monitored by the Slone Epidemiology Unit in Boston, Massachusetts. However, in spite of this, some women who were taking Accutane became pregnant each year.

In addition to addressing birth defects as a possible side effect, the new consent forms also advise patients to look for signs of depression, e.g., feelings of sadness, irritability, fatigue or loss of appetite. Health officials are not certain whether Accutane does indeed cause problems with depression, suicidal thoughts and mood disorders.

American Academy of Dermatology Issues Policy Statement on Accutane

In November 2000, the American Academy of Dermatology (AAD) issued a new policy statement on Accutane (isotretinoin, Roche), which reads as follows:

  • The Academy is committed to the safe and responsible use of isotretinoin.
  • The Academy calls on the FDA not to limit the ability of qualified patients, in consultation with their physician, to receive isotretinoin.
  • The Academy supports more education for physicians and patients on potential pregnancy hazards.
  • The Academy opposes the inclusion of isotretinoin on a list of drugs that can only be obtained by registered physicians and patients.
  • The Academy calls for a study designed to determine if there is a direct causative link between isotretinoin and psychiatric events.
  • The Academy calls upon the American Medical Association to support its efforts to ensure the continued accessibility to, and medically appropriate use of, isotretinoin.

The AAD indicated that patient safety is its primary concern, and feels that education of physicians and their patients, rather than regulation, is the best way to ensure safe and effective results with this medication.


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