Atrix Laboratories Inc received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for mometasone furoate cream USP, 0.1 per cent, a company release said.
Atrix's product is the AB-rated generic to topical Elocon Cream 0.1% which is marketed by Schering-Plough Corporation. Elocon Cream is on patent until 2007. Pending the patent expiration and final FDA approval, Sandoz Inc, a Novartis company, will market this new generic product cream.
"We are very happy with the tentative approval of this product," said David R Bethune, chairman and chief executive officer at Atrix. "We are proud of our accomplishments in this arena, and in the continued efforts to grow our dermatology business," he added.
Atrix Laboratories Inc is a pharmaceutical company focused on advanced drug delivery. With five unique patented technologies, Atrix is currently developing a diverse portfolio of proprietary products, including oncology, and dermatology products.