ClassName/CompanyApproval Dates and Comments





Schering-Plough submitted an abridged application to the US FDA and to the European Regulatory Committee (CPMP) in January 2001, to market their non-sedating antihistamine in a rapidly disintegrating tablet form for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria in adults and children >12 years of age.

Antiviral Agent

Varicella Zoster Immune Globulin



TPP-Canada approved this hyperimmune product in January 2001. VariZIG is a highly purified and specialized antibody against the varicella zoster virus that causes chicken pox.





The German Health Authorities approved this new generation antihistamine in January 2001, for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria.

Enzyme Replacement Therapy

Agalsidase Beta


Genzyme General

The US FDA completed its review of the biologics licensing application in December 2000, for this investigational enzyme replacement therapy for Fabry disease. Genzyme must supply additional data and conduct a Phase IV trial before the US FDA will give their approval.

Atopic Dermatitis Agent

ASM 981 Cream 1%

Novartis Pharmaceuticals

An NDA was submitted to the US FDA in December 2000, for this non-steroid, skin-specific cytokine inhibitor for the treatment of atopic dermatitis or eczema.

Drug News

Antiviral Agent

Docosanol 10% Cream (Abreva) was launched in January 2001, by SmithKline Beecham. It is the first OTC cold sore medication to be approved by the US FDA for reducing the healing time and duration of symptoms.

Antiviral Agent

Novartis Pharmaceuticals has acquired the antiviral products Famvir (famciclovir) and Denavir (penciclovir) from SmithKline Beecham for the treatment of herpes.

Atopic Dermatitis Agent

According to results presented at the annual meeting of the American College of Asthma, Allergy and Immunology in October 2000, topically applied strontium salts may be effective for treating itch and sensory irritation. Dr. G.S. Hahn from Cosmederm Technologies stated that when atopic subjects were treated with 20% strontium nitrate in a 5% ethanol/water vehicle vs. the vehicle alone, 70% of strontium treated sites had less itch than the vehicle treated sites. Topically applied strontium is very safe and can be found in more than 30 cosmetic and dermatological products sold around the world.

Allergic Contact Dermatitis

French researchers report that skin painting, also known as pseudo-tatooing, can lead to allergic contact dermatitis. Skin painting is done using henna, a hair dye preparation, and C.J. Le Coz, et al* stated that when henna is used on the skin, it can cause sensitization to chemical coloring agents, such as p-phenylenediamine and diaminobenzenes or diaminotoluenes.
*Arch Dermatol 136(12):1515-7 (2000 Dec)