Atrix Laboratories, Inc., an emerging specialty pharmaceutical company focused on advanced drug delivery, announced that the company received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for 3 per cent erythromycin/5 per cent benzoyl peroxide (E/BP).

In August 2003, the company announced that they had received a non-approval for this product. This approval is a reversal of that previous decision.

Atrix's product is the AB-rated generic to Benzamycin topical gel (3 per cent
erythromycin/5 per cent 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.