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FDA Approves Erythromycin/Benzoyl Peroxide
Atrix's product is the AB-rated generic to Benzamycin(R) topical gel (3% erythromycin / 5% benzoyl peroxide), which is marketed by Dermik Laboratories. This AB-rated product represents the first approval for a generic version of the popular anti-acne medication. The Novartis company, Sandoz Inc. (formerly Geneva Pharmaceuticals) will market this new E/BP product.
"This is a major victory for Atrix," said David R. Bethune, Atrix's chairman and chief executive officer. "E/BP represented not only great challenges in formulation and in demonstrating clinical bio-equivalency but also represented major regulatory challenges. We are pleased we were able to satisfy the FDA's requirements for approval."
Branded sales of Benzamycin were approximately $41 million for the year ended December 2003.
Source: Atrix Laboratories, Inc.