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FDA Approves Erythromycin/Benzoyl Peroxide

FORT COLLINS, Colo., March 30 /PRNewswire-FirstCall/ -- Atrix Laboratories, Inc. (NASDAQ:ATRX) announced today the company received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for 3% erythromycin / 5% 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(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.

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