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GLAXO TEMOVATE (CLOBETASOL PROPIONATE) HIGH POTENCY CORTICOSTEROID IS 1C APPROVAL FOR RESPONSIVE DERMATOSES; MARKET LAUNCH SCHEDULED FOR APRIL

Executive Summary

Glaxo's Temovate (clobetasol propionate) topical ointment and cream will enter the U.S. as a high potency steroid treatment for dermatologic conditions. The product, approved by FDA on Dec. 27, is indicated for short term treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses, FDA-approved labeling states. Both cream and ointment forms contain a concentration of 0.05% of the active ingredient. According to Glaxo, Temovate will be "the most potent corticosteroid available." By comparison, most formulations of hydrocortisone are in the 0.5 to 3% concentration range. The labeling states that Temovate treatment "beyond two weeks is not recommended, and the total dosage should not exceed 50 grams per week because of the potential for the drug to suppress the hypothalmic pitutitary adrenal (HPA) axis. These products are not recommended for use in children under 12 years of age." According to Glaxo, multicenter clinical trials involving over 1100 patients comparing Temovate to other corticosteroids showed that Temovate is "at the highest end of the potency spectrum." The firm said that the safety profile of Temovate is similar to that of other drugs of its class. FDA classified the product as a 1C drug, a new chemical entity representing little or no therapeutic advance. Glaxo said that clinical experience with Temovate has been accumulated over 12 years of marketing in 43 countires. U.S. distribution will begin in April, Glaxo said. The product will be priced to whslrs. at $11.28 for 15 grams and $15.60 for 30 grams of either cream or ointment. Temovate is an extension of Glaxo's line in the topical dermatologic market. The firm currently markets a 0.5% hydrocortisone product, Corticaine cream, which also contains dibucaine 0.5%.

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