Atrix Laboratories, Inc. announced that the company has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for betamethasone dipropionate cream USP, 0.05 per cent (Augmented) and a Tentative Approval for Mometasone Furoate Topical Solution USP, 0.1 per cent.
Additionally, the company has recently submitted three ANDAs to the FDA for approval of generic formulations of undisclosed dermatology products. With these applications, Atrix has six under review at the FDA.
"While the generic dermatology business is highly competitive, we are confident that our shareholders will benefit from our continued efforts to build revenue with these products," said David R. Bethune, chairman and chief executive officer at Atrix.
Atrix's product is the AB-rated generic to Diprolene AF Cream 0.05 per cent brand of augmented betamethasone dipropionate, which is marketed by Schering Plough Corporation. Betamethasone Dipropionate Cream USP, 0.05 per cent (Augmented) is a prescription topical corticosteroid product used primarily in managing inflammatory skin conditions. In 2003, branded sales of Diprolene AF cream are estimated to be approximately $50 million.
In late 2003, Atrix also received Tentative Approval from the FDA for Mometasone Furoate Topical Solution USP, 0.1 per cent, an AB-rated generic of Elocon lotion 0.1 per cent currently on patent until 2007. Both newly approved products will be marketed by Sandoz Inc., a Novartis company.