ClassName/CompanyApproval Dates and Comments

Oncologic Agent


Paclitaxel


Paxene

IVAX/Bristol-Myers Squibb

HPB – Ottawa approved this anti-cancer drug in April 2000, for the treatment of AIDS-related Kaposi’s sarcoma in patients who have failed prior liposomal anthracycline therapy.

Hormonal Preparations


Testosterone Gel


AndroGel 1%

Unimed Pharmaceuticals

The US FDA approved this once-daily topical gel in April 2000, for the treatment of low testosterone levels linked with decreased sex drive, impotence, reduced lean body mass, decreased bone density, and lowered mood and energy levels. This gel has not been evaluated in women, and should not be used in men with breast or prostate cancer.

Wound Care


“Intelligent” Dressing


Acemannan Hydrogel

Carrington Laboratories

The US FDA granted marketing clearance in March 2000, for this wound care product for the management of postsurgical incisions, first- and second-degree burns, arterial and venous stasis ulcers, pressure ulcers, and foot ulcers.

Oncologic Agent


Cyclophosphamide 25mg and 50mg tablets

Roxane Laboratories

The US FDA approved this generic form of oncologic drug in April 2000, to be used in combination with other antineoplastic therapies to treat certain forms of cancer.

Antifungal Agent


Ketoconazole 2% Cream

Teva Pharmaceuticals

The US FDA approved this generic form of antifungal cream in April 2000, for the treatment of fungal infections.

Dermatosclerosis Agent


Halofuginone

Collgard Biopharmaceuticals

The US FDA granted orphan drug designation for this drug in March 2000, for the treatment of scleroderma.

OTC Vaginal Preparations


OTC Vaginal Preparations


Clotrimazole 2% Three Day Vaginal Cream

Taro Pharmaceuticals

The US FDA approved this OTC vaginal preparation in April 2000, for the treatment of vaginal yeast infections.

Anti-psoriatic


Cyclosporine


Gengraf

Abbott Laboratories

The US FDA approved this drug in May 2000, for the prevention of organ rejection in the kidney, liver and heart transplants. Gengraf is the bioequivalent to Novartis Pharmaceutical’s Neoral.

Wound Care


Apligraf


Graftskin

Organogenesis

The US FDA’s General and Plastic Surgery Devices Panel recommended approval in May 2000, of this treatment for diabetic foot ulcers of >2 weeks’ duration. It is currently indicated for the treatment of venous leg ulcers of >1 month duration that have not adequately responded to conventional therapy.


Drug News

Wound Care

In September 1999 Regranex Gel (becaplermin 0.01% gel) (Ortho-McNeil) was launched in the UK for the treatment of diabetic ulcers. It is the first product to have a marketing authorization in Europe for this indication. It is available in the US and Canada.

Wound Care
Re: Dapsone Topical Gel

Atrix Laboratories filed an Investigational New Drug application with the US FDA in April 2000, for a trial of Dapsone topical gel (Atricaine) for the treatment of chronic itch associated with healed and healing burn wounds. Atrix utilizes its Solvent Micropartical System (SMP) drug delivery technology to permit topical administration of the normally insoluble drug.

Oncologic Agent
Re: G3139

Genta announced in May 2000, that their bcl-2 antisense compound, G3139, has recently entered Phase III trials in patients with advanced melanoma. Genta received “Fast Track” designation from the US FDA in October 1999.

Atopic Dermatitis Agents
Re:Tacrolimus Ointment

Phase III clinical trials for Tacrolimus Ointment (Protopic, Fujisawa Healthcare) has produced significant improvement for patients with atopic dermatitis. This is the first medication being developed in the US in the new topical immunomodulator (TIMs) class. It is not a steroid and works in the skin to stop the immune reaction that leads to red, itchy, inflamed rashes frequently seen in this condition.

Anesthetics, Topical

Endo Pharmaceuticals, Inc. and Elan Pharmaceuticals will co-promote Endo’s Lidoderm (lidocaine patch 5%) for pain associated with post-herpetic neuralgia.