FDA approval of topical anti-inflammatory cream

May 15 2004

Atrix Laboratories, Inc. has announced the company received approval from the U.S. Food and Drug Administration (FDA) to market fluticasone propionate cream, 0.05%. A first generic fluticasone cream to be approved by the FDA, Sandoz Inc., a Novartis company, is marketing this new generic product.

On April 27, 2004, the company announced the tentative approval of the Abbreviated New Drug Application (ANDA). Atrix's product is the AB-rated generic to topical Cutivate(R) (fluticasone propionate cream) cream 0.05%, which is marketed by GlaxoSmithKline PLC. Cutivate cream's patent expired today, May 14, 2004. This product is typically used as a topical anti-inflammatory, anti-pruritic agent.