Healthpoint Embeline E
Executive Summary
Comparisons of Embeline E (clobetasol propionate cream-emollient), a class I ranking topical steroid, to class II products like Diprolene AF are misleading because the "comparison implies that Embeline E is superior to the other product," FDA says in a May 20 letter to the company. "However, Healthpoint does not explain that there are differences in efficacy and safety with class I and class II products." The agency also object to the statement in promotional brochures that Embeline E "is the new drug of choice." "As a generic product of the innovator, Temovate E, Embeline E would not be considered a 'new drug,'" FDA said