| 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 |
