UPDATE: BioSante Pharmaceuticals Announces FDA Approval for Bio-T-Gel

BioSante Pharmaceuticals, Inc.

today announced that the U.S. Food and Drug Administration (FDA) has approved Bio-T-Gel, which is licensed by BioSante to Teva Pharmaceuticals USA, Inc. Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Male hypogonadism is generally characterized by impotence, a lack of sex drive, muscle weakness and osteoporosis. Bio-T-Gel was initially developed by BioSante, and then it was licensed to Teva for late stage clinical development. Teva is responsible for all Bio-T-Gel regulatory and marketing activities. BioSante will receive royalties and may receive certain milestone payments upon commercialization of Bio-T-Gel. The current U.S. market for male testosterone products is estimated at over $1.6 billion.