Specialty pharmaceutical company, Atrix Laboratories Inc., announced that the company has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for 0.1 per cent mometasone furoate ointment. Atrix's product is the AB-rated generic to Elocon brand of mometasone furoate ointment USP Ointment 0.1 per cent, which is marketed by Schering Plough Corporation.
In 2003, branded sales of Elocon are estimated to be approximately $17 million. Geneva Pharmaceuticals, an affiliate of Novartis AG, will market this newly approved product. "We are pleased to have our second generic topical approved this year," said David R. Bethune, Atrix's chairman and chief executive officer. "This approval, along with our earlier approval for a generic version of EMLA, represents the beginning steps in building a number of revenue-generating generic dermatology products in the next several years. This product currently has a generic competitor."