| 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 |