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Update on Drugs and Drug News - Number 4 1998

Class Name/Company Approval Dates and Comments

Scalp Dermatoses

Norgestimate / Ethinyl estradiol

Approved by the Canadian HPB March, 1998 for the new indication of treatment of moderate acne vulgaris in females who have no known contraindications to oral contraceptive therapy. Previously approved in the US in 1997.

Topical anesthetic

Lidocaine/Prilocaine Cream

Approved by the FDA February, 1998 as a pre-procedural application to adult male genital skin prior to site-specific subcutaneous infiltration with lidocaine for the removal of genital warts.

New Formulations

Acne vulgaris

Tretinoin gel 0.025%

This new gel formulation was approved by the FDA February, 1998 for the treatment of acne vulgaris.

Acne vulgaris & oily skin

Adapalene solution 0.1%

Applied once a day in the evening for the treatment of acne. The solution also provides a drying effect for patients with oily skin.

US FDA Recommendations

Wound closure

Topical tissue adhesive
Closure Medical

An FDA advisory panel recommended approval of this sterile, liquid, topical tissue adhesive to hold closed trauma-induced lacerations or surgical incisions (including punctures from minimally invasive surgery) which otherwise would be closed with sutures of USP size 5-0 or smaller in diameter, staples or adhesive strips.

Labelling Changes

Atorvastin calcium

This lipid reducing agent has been reported to cause angioneurotic edema in some patients and labelling has been changed accordingly.

Hoffman La Roche

Upon advice from the FDA in early March, Roche sent out Dear Doctor letters to US physicians advising them of labelling changes. The Warnings section will now begin with the following paragraph in bold type: Psychiatric disorders: Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide. Discontinuation of Accutane therapy may be necessary. No mechanism of action has been established for these events. The adverse events section is also revised.

In this issue:

  1. Finasteride for Male Pattern Hair Loss
  2. Tinea capitis
  3. Update on Drugs and Drug News - Number 4 1998