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Drug Treatments for Skin Disease Introduced in 2002

Drug Class Generic/Trade/
Company Names
Indication Approving
Regulatory Agency
Anti-acne Benzoyl Peroxide, Clindamycin Topical Gel
DUAC®
Stiefel Laboratories
For the treatment of acne vulgaris. This product is already available in Canada as Clindoxyl® Gel. US FDA
   

For the treatment of acne vulgaris.

UK Medicines

  Clindamycin, Zinc
Zindaclin™ Gel
Access Pharmaceuticals
  Control Agency
  Isotretinoin
Accutane®
Hoffman-LaRoche
Approval of updated labeling warning of the risk of musculoskeletal adverse effects. The new warning states that the link to Accutane® has not been established, but that care should be taken and the drug should be used no longer than the recommended duration of therapy. US FDA
  Tazarotene 0.1% Cream
Tazorac®
Allergan
Approved for two additional indications: for the treatment of acne vulgaris and photodamaged skin. TPP – Canada
Antibacterial Agents Tretinoin Gel Microsphere
Retin-A® Micro 0.04%
Ortho Neutrogena
A lower dose formulation using A.P. Pharma’s Microsponge® technology for the treatment of acne. US FDA
Anticonvulsant Agent Linezolid Injection, Tablets & Oral Suspension
Zyvox
Pharmacia
Additional indication approved for the treatment of Gram-positive infections in infants and children, which include complicated skin and skin structure infections and nosocomial pneumonia. US FDA
Antifungal Agents Gabapentin
Neurontin®
Pfizer
For the management of post-herpectic neuralgia, or pain in the area affected by herpes zoster after the disease has been treated. This product is also indicated as an addon treatment for partial epileptic seizures. US FDA
  Docosanol 10% Cream
Avanir Pharmaceuticals/
GlaxoSmithKline
Approved as an OTC topical treatment for cold sores. Korea Food and Drug Administration
  Ketoconazole 2% Cream
Ketoderm®
OptimaPharma
For the treatment of fungal infections of the skin. It is a prescription product that is bioequivalent to Nizoral® Cream (McNeil Consumer Products). TPP - Canada
  Voriconazole, IV & Oral
Vfend®
Pfizer
For treatment in immunocompromised patients with xinclude acute invasive aspergillosis; fluconazoleresistant invasive Candida; and serious fungal infections caused by Scedosporium spp. and Fusarium spp. CPMP/EMEA (Europe)
Antihistamines Cetirizine HCl
Zyrtec®
Pfizer
Approved for pediatric use to treat year round allergic rhinitis and chronic idiopathic urticaria in infants > 6months of age. US FDA
  Desloratadine Syrup & Disintegrating Tablets
Schering-Plough
For the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria in patients >2 years of age (syrup) and >12 years of age (disintegrating tablets). CPMP/EMEA (Europe)
  Desloratadine 5mg. Tablets
Clarinex®
Schering-Plough
Approved for additional indications to treat chronic idiopathic urticaria and symptoms of allergies caused by indoor and outdoor allergens in adults and children > 12 years of age. US FDA
  Loratadine
Claritin®
Schering-Plough
Approved as an OTC treatment for chronic idiopathic urticaria, or chronic hives of unknown cause. US FDA
  Loratadine 10mg. Tablets
Claritin®
Schering-Plough KK
For the treatment of allergic rhinitis, chronic idiopathic urticaria and itching associated with skin diseases in adults and children 15 years and older. Ministry of Health, Labour and Welfare – Japan
Antipsoriatic
Agents
Clobetasol Propionate Foam
Olux®
Connetics
Expanded label approved to include the short-term topical treatment of mild-to-moderate plaque-type psoriasis of non-scalp regions excluding the face and intertriginous areas. US FDA
  Etanercept
Enbrel®
Wyeth
For the treatment of active and progressive psoriatic
arthritis in adults.
CPMP/EMEA (Europe)
US FDA
Antiviral Agents Naturally Derived Alpha Interferon
Viragen
For the additional indication of treating patients afflicted with any and all diseases in which patients were, or became resistant to treatments using recombinant (synthetic) interferon.
Swedish Medical Products Agency
  Salicylic Acid 15%
Trans-Ver-Sal® Wart Removal Patch
Bradley Pharmaceuticals
For the treatment and removal of warts. Swedish Medical Products Agency
  Valacyclovir HCl
Valtrex®
GlaxoSmithKline
For the additional indication of treating cold sores in healthy adults at a dosage of 2gm po, twice daily, for 1 day. US FDA
Atopic Dermatitis

Pimecrolimus
Elidel®
Novartis
For the treatment of Atopic dermatitis in patients from as young as 3 months of age through to adulthood. CPMP/EMEA (Europe)
US FDA
Depigmenting Agents
Hydroquinone, Tretinoin & Flucinolone Acetonide Cream
Tri-Luma®
Galderma Laboratories
For the short-term treatment of moderate-to-severe melasma of the face in the presence of sun-avoidance measures, including sunscreen use.
US FDA
HIV/AIDS Efavirenz
Sustiva®
Bristol-Myers Squibb
A new one-tablet 600mg. formulation to be used in combination treatment for HIV. Provides the option of prescribing one 600mg. tablet once daily instead of three 200mg. capsules once daily. US FDA
  Rubitacan
Orathesin™
SuperGen
This product received orphan-drug designation for the treatment of pediatric patients infected with HIV and AIDS. US FDA
  Tenofovir Disoproxil Fumerate
Viread®
Gilead Sciences
For use in combination with other antiretroviral agents for the treatment of HIV infection in patients who are experiencing early virological failure.
CPMP/EMEA (Europe)
Immune Response Modifier Imiquimod 5% Cream
Aldara®
3M Pharmaceuticals
For the additional indication of treating external genital and perianal warts and conylomata acuminate in adolescents >12 years of age. A new dosage was also approved: application of a thin layer to warts at h.s. three times weekly for a maximum of 16 weeks. US FDA
Immunomodulatory Agents Cyclosporine capsules 25mg, 100mg
Apotex Corp.
This generic immunosuppressant is the equivalent of Novartis Pharmaceuticals’ Sandimmune®. US FDA
Oncologic Agents HSPPC-96
Oncophage®
Antigenics
This cancer vaccine was granted fast-track designation for the treatment of metastatic melanoma. US FDA
Oral Contraceptive

Estradiol/Levonorgestrel
Alesse®
Wyeth-Ayerst Canada

For the treatment of moderate acne in women. TPP – Canada
Photoaging Tazarotene Cream 0.1%
AVAGE™
Allergan
Approved as an adjunctive agent in the topical treatment of fine facial wrinkling, mottled hypo and hyperpidmentation, and benign facial lentigines in patients using a comprehensive skincare and sunlight avoidance program. US FDA
Photodynamic Therapy Metvix® Photodynamic Therapy
Photocure ASA
For the treatment of actinic keratosis and basal cell carcinoma in patients for whom traditional therapies are unsuitable. New Zealand’s Regulatory Authority
Wound Care Sodium Hyaluronate
LAM IPM Wound Gel®
LAM Pharmaceutical
For the treatment of refractory leg and foot ulcers. US FDA



  1. Cutaneous Leishmaniasis of the Old World
  2. Drug Treatments for Skin Disease Introduced in 2002