Atrix Laboratories, Inc., a specialty pharmaceutical company focused on advanced drug delivery, announced the company received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for fluticasone propionate cream, 0.05 per cent.
Atrix's product is the AB-rated generic to topical Cultivate (fluticasone propionate cream) cream 0.05 per cent, which is marketed by GlaxoSmithKline PLC. This product is typically used as a topical anti-inflammatory, anti-pruritic agent. The estimated market for branded sales of the product was $24 million in 2003.
This AB-rated product represents the first tentative approval for a generic version of the popular topical corticosteroid. Cultivate cream is on patent until May 14, 2004. Pending the patent expiration, Sandoz Inc., a Novartis company, will market this new generic fluticasone cream upon final FDA approval.
"I am pleased with the tentative approval of fluticasone cream," said David R. Bethune, chairman and chief executive officer at Atrix. "This approval represents continuing success with the joint venture between Atrix and Sandoz. We expect to continue to build this division over the coming year as we anticipate additional approvals in 2004."