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Update on Drugs and Drug News - Number 2 2000

Class Name/Company Approval Dates and Comments

Transdermal Agents

Estradiol Transdermal System
Novoagyne Pharmaceuticals

The US FDA approved the additional indication of postmenopausal osteoporosis in August 2000, for this transdermal estrogen patch. Vivelle has been available for the treatment of menopausal symptoms since March 1996.

Antibacterial Agents

Levofloxacin Tablets/Injection
Levaquin Tablets/Injection
Ortho Pharmaceuticals

The US FDA approved an additional indication of treating complicated skin and skin structure infections at a higher dose of 750mg once daily in September 2000. This is the ninth indication for Levaquin, which has been marketed in 250mg and 500mg doses since 1993.


Tretinoin Cream
Renova 0.02%
Ortho Pharmaceuticals

The US FDA approved this new formulation in August 2000, for reducing fine facial wrinkles associated with chronic sun exposure and the natural aging process. This new Renova formulation must be used as part of a total skin care and sun protection program. It is expected to be available by prescription in November 2000.


Tretinoin Cream
Renova 0.05%
Ortho Pharmaceuticals

The US FDA approved a new indication in September 2000, as an adjunctive agent for use in the mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who use comprehensive skin care and sunlight avoidance programs.

Vaginal Preparations

Butoconazole Nitrate
Gynazole 2% vaginal cream
KV Pharmaceuticals

The US FDA approved this vaginal cream in June 2000, for the treatment of vaginal yeast infections with only one dose. It is available by prescription in prefilled applicators for use during the day or night.

Antiviral Agent

Docosanol 10% Cream
Avanir Pharmaceuticals

The US FDA approved this antiviral agent in July 2000, for the treatment of recurrent oral-facial herpes simplex infections. It is the first FDA approved cold sore treatment to be available OTC.

Atopic Dermatitis Agents

Tacrolimus Ointment
Fujisawa Healthcare

An NDA was submitted to the US FDA in July 2000, for this ointment for short and long-term treatment of the signs and symptoms of atopic dermatitis in adults and in children 24 months and older.

Drug News

Antirejection Agents

Sangstat Medical Corporation voluntarily recalled the generic form of cyclosporine (SangCya) in July 2000, because it was found not to be bioequivalent to Neoral oral solution when mixed with apple juice as recommended in its labelling. The US FDA approved this generic formulation in May 1999.

AIDS Related Kaposiís Sarcoma

Officials from the Centers for Disease Control and Prevention in Atlanta, Georgia, say that the incidence of AIDS related Kaposiís sarcoma (KS) continues to decline in the US, thanks in large part to the widespread use of effective combination antiretroviral therapies. Between 1990 and 1998, the incidence of KS declined approximately 8.8%.

In this issue:

  1. Perspectives on Isotretinoin and the Canadian Consensus Guidelines on Treatment of Acne
  2. US FDA Advisory Committee Meetings Held to Discuss Isotretinoin, Safety Issues and a New Accutane Formulation
  3. Update on Drugs and Drug News - Number 2 2000