Class Name/Company Approval Dates and Comments

Anti-AIDS


Efavirenz

Sustiva®

Du Pont

Approved by the US FDA September, 1998 for the treatment of HIV-1 in both adult and pediatric patients. Efavirenz is a nonnucleoside reverse transcriptase inhibitor which has the advantage of once daily dosing.


Nevirapine

Viramune®

Boehringer Ingelheim

Approved by the US FDA September, 1998 for use in combination therapy with other antiretroviral agents for treatment of HIV-1 infection.

Antiherpes


Famciclovir

Famvir®

SmithKline Beecham Pharma

Approved by the US FDA July, 1998 for the suppression of genital herpes in immunocompetent adults.

Antihistamine


Cetirizine

Zyrtec®

Schering

Approved by the US FDA June, 1998 for the treatment of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria in children aged 2–5 years; it was previously approved for patients six years of age and above.

Anti-TB


Rifapentine

Priftin®

Hoechst Marion Roussel

Approved by the US FDA June, 1998 for use in combination therapy of TB. Rifapentine will be given twice weekly for two months and then once weekly for the final six months.

Cutaneous
T-cell lymphoma


Denileukin diftitox

Ontak®

Seragen®

An FDA committee has recommended approval of denileukin diftitox for treating cutaneous T-cell lymphoma, it has been designated an orphan drug by the FDA.

Kaposi’s sarcoma


Doxorubicin

Caelyx®

Schering Canada

Canadian approval has been granted to this liposome encapsulated doxorubicin for the treatment of Kaposi’s sarcoma.

Skin substitute


Graftskin

Apligraf®

Novartis

Approved by the US FDA in July 1998 for the treatment of venous leg ulcers; in Canada, it was approved for this same indication in April, 1997. Apligraf® was the subject of a two part review in issues 2:5 and 2:6 of this Letter.


Drug News

Dangers of alternative medicine

A New Engl J Med 1998; 339: 839–841 editorial states that there is only medicine that has been adequately tested and medicine that has not, rather than two kinds of medicine—conventional and alternative. At present, the only requirement on herbal products is that they cannot claim to prevent or treat disease.
Alternative medicine should pass the same FDA testing as conventional medicine.

Protease inhibitors during pregnancy

The National Institutes of Health have temporarily suspended enrollment of pregnant women into clinical trials of protease inhibitors, citing an unexpected number of premature births; of 10 babies studied, three were premature and one died in utero.