Atrix Laboratories Inc has submitted two Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration (FDA) for approval of generic formulations of topical dermatology products. Late 2001, Atrix submitted ANDAs for two additional topical generic formulations bringing the total to four ANDAs submitted in less than nine months.
"Moving these dermatology products toward market introduction is one of the important objectives of our company," said David R. Bethune, chairman and chief executive officer.
David Osborne, vice president of Atrix''''''''''''''''s dermatology division commented, "Developing formulations and preparing ANDAs for topical dermatology products contains an added dimension of complexity not commonly associated with generics products development. The expertise and dedication of the Atrix dermatology team is what allows us to move multiple topical products rapidly toward ANDA submission and FDA review."
Atrix is currently developing a diverse portfolio of proprietary products, including oncology, pain management, and dermatology products. The company also partners with large pharmaceutical and biotechnology companies to apply its proprietary technologies to new chemical entities or to extend the patent life of existing products.